EXTERNAL INSTRUCTION

REQUIREMENTS FOR
REGISTRATION, RE-REGISTRATION AND
MODIFICATION OF THE HEALTH
NOTIFICATION FOR HOMEOPATHIC
PRODUCTS OR MEDICINES

Version [1.0]

General Technical Coordination of Certifications

Technical Direction of Sanitary Registration,
Mandatory Health Notification and Authorizations
September, 2023
THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH
SHOULD NOT BE USED FOR ANY PURPOSE OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE
UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE INSTITUTIONAL REPOSITORY.
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CHANGE CONTROL

Version Description Date of Update

Modifications:
• The instructions for registration, modification and re-
registration of homeopathic medicines are unified.
• Definitions are included.
1.0 September/2023
• See includes guidelines, requirements y
processes in accordance with
Resolution ARCSA-DE-2023-012-ARKG.
• Update of the instructive format with the new
governmental image.

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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CONTENTS

1. OBJECTIVE OF THE INSTRUCTIONS...............................................................................................5

2. LEGAL BASIS.................................................................................................................................5
3. DEFINITIONS ................................................................................................................................6
4. GENERAL CONSIDERATIONS ........................................................................................................8
5. REGISTRATION OF THE HEALTH NOTIFICATION .........................................................................10
5.1. GENERAL REQUIREMENTS TO BE ATTACHED TO THE APPLICATION FORM .......................10
5.2. ADDITIONAL REQUIREMENTS FOR FOREIGN HOMEOPATHIC PRODUCTS TO BE
ATTACHED TO THE APPLICATION..................................................................................................18
6. RE-REGISTRATION OF HEALTH NOTIFICATION ...........................................................................20
6.1. AUTOMATIC RE-ENROLLMENT..........................................................................................20
6.2. RE-REGISTRATION WITH TECHNICAL DOCUMENTARY REVIEW .........................................20
7. MODIFICATION OF THE HEALTH NOTIFICATION ........................................................................21
7.1. CASES REQUIRING A NEW HEALTH NOTIFICATION............................................................21
7.2. CASES THAT DO NOT REQUIRE A NEW HEALTH NOTIFICATION.........................................21
8. ANNEXES ...................................................................................................................................31
8.1. Annex 1: Signed letter detailing the list of documents attached to the application. 31

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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1. OBJECTIVE OF THE INSTRUCTION

To guide the external user in a detailed, clear and precise way about the requirements to be
attached and the procedure to be followed through the Ecuadorian Single Window - VUE for the
processes of Registration, Re-registration and Modification of the Sanitary Notification of
Homeopathic Products or Medicines.

2. LEGAL BASIS

• Article 137 of the Organic Health Law establishes that: "Processed foods, food additives,
cosmetics, hygienic products, nutraceutical products, homeopathic products, pesticides for
domestic and industrial use, and other products for human use and consumption defined
by the National Health Authority, manufactured in the national territory or abroad, for
their import, marketing and sale (...) are subject to obtaining a sanitary notification prior
to their commercialization (...)".

• Organic Law for Digital and Audiovisual Transformation, published in Official Gazette Third
Supplement No. 245, on February 7, 2023, states: "Article 22.- Implementation of the
electronic signature. The different agencies of the public administration, as well as the
private sector, shall implement and accept within their different processes the use of the
electronic signature by the administered parties.
The use of the handwritten signature in the different processes of the public
administration or the private sector shall be at the discretion of the person concerned".

• Law on Electronic Commerce, Signatures and Data Messages, published in Official Gazette
Supplement 557, on April 17, 2002, states: "Art. 14.- Effects of the electronic signature:
The electronic signature shall have the same validity and shall be recognized as having the
same legal effects as a handwritten signature in relation to the data recorded in written
documents, and shall be admitted as evidence in court".

• By means of Memorandum No. ARCSA-ARCSA-DAJ-2023-0202-M, dated March 28, 2023,

the Directorate of Legal Counsel, cites: "(...) the recommendation made in the SPECIAL
EXAMINATION DECONTRALORÍA No. DPGY-0133-2022, I must indicate that the Organic
Law of the Comptroller General of the State is clear in determining in its ART. 92:

"Article 92 - Audit recommendations - Audit recommendations, once communicated to the

State institutions and their employees, must be applied immediately and in a mandatory
manner; they shall be followed up and their non-observance shall be sanctioned by the
Office of the Comptroller General of the State".

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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In accordance with the provisions of Art. 22, paragraph d) of the General Regulations to
the Organic Law of the Comptroller General of the State, which determines:

"Art. 22.- Communication of results: During the course of an audit or special examination,
government auditors shall maintain constant communication with public servants, former
public servants and other persons related to the control action, giving them the
opportunity to present documented evidence, as well as written information related to the
matters under examination.
Provisional results for each part of the examination will be released as soon as they are
finalized for the following purpose:
[...] d. Facilitate the implementation of the recommendations that, in accordance with
Article 92 of the law, must be applied immediately and mandatorily by the owner and
responsible officials.

• And that in addition to being mandatory, the recommendation made by means of the
SPECIAL EXAMINATION OF CONTRALORÍA No. DPGY-0133-2022 is in harmony with the
provisions of Article 22 of the Organic Law for the Digital and Audiovisual Transformation
(...)".

• These external instructions are in accordance with Resolution ARCSA-DE- 2023-012-AKRG,

which issued the Substitute Technical Sanitary Regulations for the Sanitary Notification of
Homeopathic Products or Medicines and Good Manufacturing Practices for Homeopathic
Pharmaceutical Laboratories, published in Official Gazette 330 of June 13, 2023;

3. DEFINITIONS

Homeopathic strain or mother tincture: Any primary preparation, from raw materials of animal,
vegetable or mineral origin, used as a starting point for the preparation of homeopathic dilutions.

Manufacturer - A national or foreign natural or juridical person recognized and documented by

the health authorities of the country of origin, to whom, by virtue of the legislation in force in the
country, authorization has been granted for the manufacture and packaging of the homeopathic
product or medicine.

Homeopathic medicine - It is the pharmaceutical preparation obtained by homeopathic

techniques, according to the rules described in the official pharmacopoeias accepted in the
country, with the purpose of preventing disease, alleviating, curing, treating and rehabilitating a
patient. Containers, labels, tags and packages are an integral part of the medicine, since they
guarantee its quality,

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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stability and adequate use. They must be prescribed by professionals authorized for this purpose
and dispensed or sold in places authorized for this purpose.

The homeopathic pharmacopoeias of Spain, France, Germany, England, United States, Mexico, Italy,
Brazil, India and others accepted as such by the National Health Authority are recognized as official
in the country.

For the purposes of these regulations, the terms "homeopathic drug" or "homeopathic product"
shall be used interchangeably.

Commercial name of the product or trademark - Any sign, special name or emblem that traders or
industrialists adopt or apply to their product to distinguish it from other homeopathic products is
considered a commercial name or trademark.

Sanitary Notification - It is the certification granted by the National Agency of Regulation, Control
and Sanitary Surveillance, for the import, export and commercialization of products for human
use and consumption indicated in the Organic Law of Health. Said certification is granted when
the requirements of quality, safety, efficacy and aptitude to consume and use said products are
met, complying with the procedures established in the Organic Law of Health, regulations and
technical norms regulated by the agency in this regard.

Operating Permit - This is the document granted by the national health authority to
establishments subject to sanitary control and surveillance that comply with all the requirements for
their operation established in the corresponding regulations.

Term - Term shall be understood as calendar days, i.e. every day of the week, including Saturdays,
Sundays and holidays.

Digital Prospectus - Digital reference by means of a link code to a website designated by the
ARCSA, where the updated information, approved by the Agency, corresponding to the product's
prospectus can be consulted.

Leaflet or Insert: It is the informative leaflet for the user included as part of the drug packaging.

Technical representative: All third level professional degrees of Pharmaceutical Chemists or

Pharmaceutical Biochemists, conferred by a Higher Education Institution recognized by SENESCYT,
to exercise technical responsibility.

Applicant. - It is the natural or legal person who requests the sanitary notification of the
homeopathic medicine, being the manufacturer, proxy or distributor authorized for this purpose.
A
THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
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Once the health notification certificate has been granted, the applicant becomes the Health Notification
Holder.

Correct - Correct an error in information, documentation, process, or take corrective action to comply
with an applicable regulatory requirement.

Term - A period of time in which only working days are counted.

Owner of the product - The natural or legal person who is the owner of the p r o d u c t , which must be
documented.

Holder of the Sanitary Notification - Natural or legal person in whose name the sanitary notification is
issued and who is responsible for the quality and safety of the product.

4. GENERAL CONSIDERATIONS

• For the purposes of these regulations, the terms "homeopathic drug" or "homeopathic
product" shall be used interchangeably.

• Registration, re-registration and modification of the Health Notification are subject to the
payment of the amounts established in the current ARCSA fee regulations.

• The application for Registration, re-registration and modification of the sanitary

notification will be made electronically to the National Agency of Regulation, Control and
Sanitary Surveillance - ARCSA, through the Ecuadorian Single Window (VUE) of the
ECUAPASS Web Portal, for which the applicant must fill out an individual application form
for each pharmaceutical form and compounding formula.

• The National Agency of Regulation, Control and Sanitary Surveillance - ARCSA, will be
responsible for receiving and verifying that the information presented in the application
complies with the Technical Sanitary Regulations Substitute for Sanitary Notification of
Homeopathic Products or Medicines, and Good Manufacturing Practices for Homeopathic
Pharmaceutical Laboratories in force, in order to grant or deny the Sanitary Notification.

• In order to obtain the sanitary notification, the documents attached to each application
shall be submitted in Spanish or in English with their official translation into Spanish when
the language of origin is different from those mentioned; they must be identified and
electronically signed by the technical responsible and legal representative in Ecuador.

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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• In order to obtain the sanitary notification, the user shall enter in the computer system all
the documents and requirements established in Resolution ARCSA-DE-2023- 012-AKRG or
document that substitutes or modifies it. In case the computer system does not allow
attaching any additional document due to its capacity, it shall be delivered by official
letter and in magnetic media (CD) to the Zonal Coordination Offices or Central Plant of the
National Agency of Regulation, Control and Sanitary Surveillance - ARCSA.

• Once the user enters the application form and the established attached documents,
ARCSA will carry out the documentary review, by means of a checklist (this review of the
form does not correspond to the analysis of the technical-legal documentation entered by
the user).

• In the event that the review is not favorable, the process will be returned to the user only
once so that he/she may correct the observation within five (5) days. If this is not done
within the established time or if the observation is not corrected, the application will
reflect the status of "application not approved" and the process will be definitively
cancelled.

• If the review of the application is favorable, the system will notify you of the amount to be
paid, after which you will have ten (10) days to pay the corresponding amount (fee),
otherwise your application will reflect the status of "application not approved" and will be
canceled definitively.

• ARCSA will generate the invoice in the name of the data established by the applicant for
the invoice and after payment, ARCSA will perform the technical-chemical and safety-
efficacy analysis.

• In case the technical-chemical or safety-efficacy analysis report has no objections, the

respective sanitary notification certificate will be issued.

• In the event that the technical-chemical or safety-efficacy analysis contains observations,

a report of objections will be generated through the system, which will authorize the user
to save them for the first time, within a maximum term of 30 days for products of national
manufacture and a maximum term of 60 days for products of foreign manufacture.

• In case the objections have not been adequately overcome, ARCSA will authorize for the
second and last time the user to overcome the observations of the initial objections
report, in a maximum term of 30 days for products of national manufacture and a
maximum term of 60 days for products of foreign manufacture.

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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• Once the corrected objections are received, if they are favorable, the respective
Certificate of Sanitary Notification will be issued.

• If the objections have not been corrected or have not been submitted within the
established time, the process will be definitively cancelled.

• In the event that the process is declared cancelled for failure to submit the corrected
objections or within the established time after the technical-chemical or safety-efficacy
analysis, the amount paid for registration or modification of the sanitary notification will
not be refunded.

• During the process of granting the sanitary notification, the modality of sale of the
homeopathic product will be determined, i.e. whether it is for sale over-the-counter or
under medical prescription.

• The homeopathic pharmacopoeias of Spain, France, Germany, England, United States,

Mexico, Italy, Brazil, India and others accepted as such by the National Health Authority
are recognized as official in the country.

• The technical documents requested for registration, modification or re-registration

processes must be duly signed by the technical manager or submit a letter detailing the
attached documents, duly signed by the technical manager and legal representative in
Ecuador (See Annex 1).

• The letter detailing the attached documents may be submitted physically or electronically.
If the document is submitted electronically, it must contain the electronic signatures of
responsibility. In the case of handwritten signatures, it will be necessary to upload the
document in PDF format and also physically present the original document at the ARCSA
Central Plant or at the nearest Zonal Coordination.

• The aforementioned document, in which more than one signature is consigned, all of
them must be made under the same modality, i.e. handwritten or electronic.

5. REGISTRATION OF THE HEALTH NOTIFICATION

5.1. GENERAL REQUIREMENTS TO BE ATTACHED TO THE APPLICATION FORM

The documents listed below must be attached to the sanitary notification application form (all the
information declared in these documents must be in accordance with the applicable sanitary
legislation in force). The documents must be duly signed by the technical responsible or a letter
must be presented detailing the

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attached documents, duly signed by the technical manager and legal representative in Ecuador (See
Annex 1).

a) Justification of homeopathic therapeutic use, contraindications, warnings, interactions,

side effects and precautions for use: referenced in homeopathic pharmacopoeias,
journals and recognized publications.

The holder of the sanitary notification must support that the homeopathic strain is described
in the pharmacopoeia and must attach the information where the support is described.
(Summary, links or links are not accepted, neither see annex).

b) Draft external and internal labels to be marketed in the country, written in Spanish, with
clearly legible and indelible characters.

The draft label shall detail the dimensions in which the homeopathic product is to be
marketed and other requirements:

External labels should contain the following information:

a. Name of the homeopathic medicine.
b. Scientific denomination of the corresponding homeopathic strain or strains,
followed by the dilution, using the name and symbol, in accordance with the official
homeopathic pharmacopoeia used.
c. Pharmaceutical form.
d. Route of administration.
e. Package contents.
f. Specific precautions for conservation, when applicable.
g. Lot number.
h. Date of manufacture.
i. Expiration date.
j. Health notification number.
k. Manufacturer's name, city and country.
l. Name and address of the person responsible for marketing in the country.
m. In case of p r e s c r i p t i o n products: Warning "Use: under medical prescription
and supervision".
n. Precautions, contraindications and warnings submitted f o r the health
notification process.
o. For OTC products, therapeutic indications and posology must be detailed.
p. It must bear the following mandatory legends:
i. "Homeopathic Medicine.
ii. "Over-the-counter" or "Prescription", as applicable.
THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
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Internal labels should contain the following information:

a. Name of homeopathic medicine

b. Pharmaceutical form.
c. Route of administration.
d. Container contents
e. Specific precautions for conservation, when applicable.
f. Lot number.
g. Date of manufacture.
h. Expiration date.
i. Health notification number.
j. Manufacturer's name, city and country.
k. In case of p r e s c r i p t i o n products: Warning "Use: under medical prescription
and supervision".
l. It must bear the following mandatory legends:
i. "Homeopathic Medicine.
ii. "Over-the-counter" or "Prescription", as applicable.
m. If the size of the package allows it, precautions, contraindications and warnings
can be presented for the health notification process.

The label project with the specifications and dimensions, artwork, graphics and texts with
which it will be marketed in Ecuador must be in Spanish language, in clearly legible and
indelible characters.

All advertising information must be in accordance with the provisions of the Regulations
for Advertising and Promotion of Medicines in General, Processed Natural Products for
Medicinal Use, Homeopathic Medicines and Medical Devices.

No pharmacological properties or therapeutic indications for medicinal use, nor drawings

alluding to such properties, will be accepted in the commercial name of the product.

For homeopathic products for FREE SALE (When this condition is declared), the following
requirements shall be declared in addition to those described:

1. Therapeutic indications and instructions for use;

2. Posology;
3. Precautions for use;
4. Contraindications, according to safety and efficacy studies and current
pharmacological standards;
5. If symptoms persist, consult your physician.
THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
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If the size of the primary container does not allow the inclusion of all the required data on
the label, the label must include at least the following information:

1. Name of the homeopathic medicine;

2. Scientific denomination of the corresponding homeopathic strain or strains,
followed by the dilution, using the name and symbol, in accordance with
the official homeopathic pharmacopoeia used;
3. Pharmaceutical form.
4. Route of administration.
5. Package contents;
6. Name of the manufacturing laboratory;
7. Expiration date;
8. Lot number;
9. Health notification number;
10. Retail price;
11. Name of the holder of the health notification

c) Prospectus

The information that must be included in the package insert attached to the product is as follows:

a. Commercial name of the product or trademark;

b. Quantitative composition of the homeopathic strain used and qualitative composition in excipients;
c. Name and address of the health notification holder and of the product holder;
d. Product information:
i. Scientific name of the homeopathic strain and the dilution used in accordance
with the pharmacopoeia used;
ii. Pharmaceutical form;
iii. Approved therapeutic indications.
e. Information before using the product:
i. Contraindications;
ii. Precautions for use and warnings;
iii. Interactions, as appropriate.
f. Usage information:
i. Instructions for use;
ii. Route of administration;
iii. Posology and duration of treatment;
iv. Symptoms in case of overdose and actions to be taken.
g. Adverse Reaction Information:
i. Description of adverse effects or adverse reactions;

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OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
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ii.In the event that there are no reports of adverse reactions, the following will be
indicated: "There are no known, there are no studies of this product on adverse
reactions, therefore, if you have any type of adverse reaction during or after
consuming this product, immediately inform ARCSA and the holder of the health
notification".
h. Product storage information:
i. Storage conditions;
iii. Warnings about certain visible signs of deterioration of the container;
i. Legends:
i. "Read the entire package insert before starting to use this product."
ii. "If you need additional information, consult your physician."
iii. "In the event of adverse effects, immediately contact ARCSA and the health
notification holder."
iv. "This product should not be administered to children, a visit to a physician is
recommended"; only for products that have not been shown to be safe for use in
all age groups of the population.

Prescription homeopathic medicines must present the physical package insert. Over-the-
counter homeopathic medicines may attach the leaflet or insert by means of a QR code.

In the case of homeopathic medicines that have only primary packaging and require the
package insert to be included, it should be enclosed in such a way that it is not easily
detachable.

d) Modality of Sale

To classify homeopathic medicines as OTC, the following criteria must be met:

a. That have demonstrated efficacy and safety for use in the prevention, relief of
symptoms or signs of mild, easily identifiable diseases;
b. That they have a wide safety range, so that the voluntary or involuntary
administration of doses higher than those recommended does not represent a
serious danger to the patient's health;
c. That they have a wide dosage range, which can be adapted to the age and weight
of the patient;
d. That their use does not generate tolerance or dependence and that they are not
susceptible to abuse;
e. That when used as directed, they do not mask serious illnesses or delay diagnosis
and treatment of a condition requiring medical attention;
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OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
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f. That its use is safe in all age groups of the population;

g. The dosage forms are for oral (O.V.) or topical administration, and not for
intravenous (IV) or intramuscular (IM) administration.
h. That adverse reaction reports have not increased during the marketing period.

e) Stability studies of the homeopathic product, carried out based on ICH or USP criteria for
climatic zone IV.

The stability study shall be submitted with the name, signature and position of the technician
responsible for the laboratory that performed the study. It can be performed by the manufacturer
as long as the company has the capacity to perform such study, in case it does not have a quality
control laboratory, the stability study can be outsourced to a laboratory that has the technical and
legal capacity to perform these studies.

The stability study should contain at least the following information:

1. Stability test performed, whether natural or accelerated;

2. Manufacturer's laboratory, city and country of origin;
3. Name of the product and the amount of the active/marker contained in the product;
4. Pharmaceutical form and description;
5. Lot number and lot size;
6. Date of initiation and completion of the study;
7. Temperature in degrees Celsius (°C) and percent relative humidity (% R.H.) at which the
study was conducted;
8. Nature and type of full container: glass or plastic or the material used in which the study
was carried out;
9. Physical-chemical and microbiological parameters according to the pharmaceutical form
and the active ingredient;
10. Specifications and results obtained at appropriate time intervals;
11. Conclusions, in which the manufacturer proposes the shelf life period in which it
guarantees the quality of the product; it must bear the original signature, name and
position of the technician responsible for the study and the storage conditions of the
samples, specifying the storage temperature;

Stability studies by natural or accelerated aging corresponding to Zone IV are accepted as

specified in the ICH Guideline (ICH Q1F Guideline. Stability testing of active pharmaceutical
ingredients Zone III & IV. WHO Technical Report Series, No. 953, 2009) and at least three different
batches are required for the study.

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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HOMEOPATHIC MEDICINES

Natural stability: The duration of the study should correspond to the proposed shelf life and
should include results at appropriate time intervals (0, 3, 6, 6, 9, 12, 18, 24, 36, 48, 60 months);
homeopathic products kept refrigerated are excluded and the stability record should state the
temperature in degrees Celsius (°C) and % R.H. at which the study was carried out.

In the case of powder to reconstitute a suspension or reconstitute an oral solution and injectables
for non-immediate use, the stability data sheet for powder and for the reconstituted dosage form
at room temperature, IV climatic zone and/or refrigeration, as appropriate, must be attached to the
application.

In case of solutions or syrups, once the container has been opened, declare the time and
conditions of maintenance of the same; attaching stability data sheet that responds to the period
of validity assigned by the manufacturer.

Accelerated stability: To be performed in accordance with the international methodology

recognized in the regulatory codes (ICH Q1F Guideline. Stability testing of active pharmaceutical
ingredients Zone III & IV. WHO Technical Report Series, No. 953, 2009). Accelerated stability
methods cannot be applied to products that do not have established quantification methods.
When the accelerated stability study is presented, it does not exclude the development by the
manufacturer of the corresponding natural stability study, which will include the respective
microbiological stability study.

Accelerated studies, of at least three different batches, conducted at 40 degrees Celsius ± 2

degrees Celsius and 75% ± 5% relative humidity, with a duration of six months, accompanied by a
natural stability study, of at least three different batches, under humidity and temperature
conditions corresponding to climatic zone IV, with a duration of 12 months or at least 6 months
(provided that the active ingredient is recognized as stable and no significant change is observed
during the stability studies under accelerated conditions) at the time the product enters the
sanitary notification process, are accepted as a scope. The applicant for sanitary notification must
submit a letter of commitment indicating that it will submit the complete stability studies once its
proposed shelf life has expired.

f) Manufacturing Process.

Attach flow diagram and definition of each of the steps to be followed, this document must be
issued by the manufacturer and must include the signatures of responsibility.

g) Scientific name of the stock(s) or mother tincture(s).

According to the pharmacopoeia accepted by the country.

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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h) Certificate of identification of the homeopathic strain and its origin.

Technical data sheet of each homeopathic strain that is part of the homeopathic product, this
information is obtained from the supplier of the raw material.

i) Certificate of Good Manufacturing Practices.

Pharmaceutical Laboratories of homeopathic medicines, which have a valid operating permit,

have a maximum term of 5 years, counted from the publication of Resolution ARCSA-DE-2023-
012-AKRG in the Official Gazette 330 of June 13, 2023, for the implementation and execution of
the standards of Good Manufacturing Practices.

Pharmaceutical laboratories of new homeopathic medicines, prior to obtaining the Operating

Permit, must obtain the GMP certification. (See Instructions: Requirements and Procedures for
Obtaining, Renewal, Extension, Inclusion of pharmaceutical forms and Modification of the Good
Manufacturing Practices (GMP) Certificate for Pharmaceutical Laboratories of Homeopathic
Medicines).

In case of failure to obtain GMP within 5 years, a favorable inspection report must be attached.

j) Quality specifications of raw materials.

Raw material data sheet including excipients.

k) Quality specifications of the finished product.

This document consists of a declaration by the applicant stating the tolerance limits for each of
the tests performed (organoleptic, physical-chemical, chemical and microbiological analysis); for
which, it must meet the general requirements for the corresponding dosage form; method with
bibliographic reference and with the signature of a responsible technician of the manufacturing
laboratory.

The minimum aspects to be included in the test shall be:

1. Product Name;
2. Pharmaceutical Form;
3. Commercial presentation;
4. Organoleptic, physical-chemical, chemical and microbiological characteristics.

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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OR SERVICES
HOMEOPATHIC MEDICINES

l) Technical specifications of primary and secondary packaging material.

Physical-chemical specifications with the description of the nature of the primary and/or
secondary packaging, issued by the manufacturer. Justify that the material is suitable for use in
medicines or medicinal products for human consumption; with signature, name and position of the
responsible technician.

m) Batch code interpretation.

It refers to the description of the meaning of each of the numbers, letters or signs that the
manufacturer is using to identify its production, this code allows establishing the traceability of
the product. The document must be signed with the name and signature of the person technically
responsible for its elaboration.

n) Analytical methodology used for finished product analysis.

Document specifying the homeopathic pharmacopoeia method used.

o) Attachments with additional arguments

Additional information may be attached to allow the technical analyst to have more support or
evidence for the analysis in case of particularities of the product to be registered.

p) Contract manufacturing

In case the manufacturer of the homeopathic product is different from the holder of the health
notification, the legalized or notarized contract containing the following information must be
submitted: the name or company name of the contracting party and contractor and their
identification number (identity and citizenship card, passport or RUC).

5.2. ADDITIONAL REQUIREMENTS FOR FOREIGN HOMEOPATHIC PRODUCTS THAT MUST BE

ATTACHED TO THE APPLICATION

In addition to the requirements indicated above, the following requirements, duly apostilled or
consularized, must be attached in order to obtain the sanitary notification for foreign
homeopathic products or medicines:

a. Power of attorney duly legalized or apostilled, granted by the owner of the homeopathic
product in the country of origin, to the natural or legal person who represents him/her
in Ecuador to register, import and commercialize: In which the applicant is authorized to
obtain the Sanitary Notification in Ecuador.
THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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OR SERVICES
HOMEOPATHIC MEDICINES

b. Manufacturing contract, in case the manufacturer of the homeopathic product is different

from the owner of the product, the legalized or apostilled contract must be submitted
containing the following information: the name or company name of the contractor and
contractor and its identification number (identity and citizenship card, passport or RUC).

c. Certificate of free sale or equivalent document issued by the competent sanitary

authority of the manufacturer country of the foreign product, duly apostilled or
consularized as appropriate, stating the following information:

▪ Product name
▪ Trademark
▪ Complete quali-quantitative composition formula. When it is not declared in the
CLV, this information must be attached in a sheet with stamp and signature of
the responsible technician of the manufacturing laboratory;
▪ Pharmaceutical form;
▪ Description of the pharmaceutical form;
▪ Commercial presentation.

The CLV or its equivalent shall guarantee:

1) That the manufacturing laboratory is legally established in the country of origin of

the product;
2) That the manufacturing laboratory operates in accordance with the Good
Manufacturing Practice Standards of the country of origin;
3) That the manufacturing laboratory is subject to periodic supervisions by the
Competent Health Authority of the country of origin of the product;
4) That the product complies with the technical and legal requirements for the
Sanitary Notification or Certificate of Free Sale in its country of origin;
5) That it is sold freely in the country of origin and that it is not a product
manufactured exclusively for export, with the exception of the following cases:

▪ The product has been developed exclusively for the treatment of non-
endemic diseases in the exporting country;
▪ The product has been reformulated to improve its stability under the climatic
conditions of Ecuador;
▪ The product has been reformulated to exclude excipients not approved for
use in pharmaceutical products in Ecuador;
▪ The product has been reformulated to find a different maximum dosage limit
of an active ingredient;

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
 EXTERNAL INSTRUCTION CODE IE-B.3.2.1-MH-01
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OR SERVICES
HOMEOPATHIC MEDICINES

▪ The product for commercial reasons is not sold in the country of origin, but
has no sanitary objection according to the declaration of the corresponding
sanitary authority in the country of origin and the country to which it is
exported; and,
▪ When the product is manufactured under contract for the holder of the
sanitary notification. In this case the Certificate of Free Sale or its equivalent,
must guarantee that the product does not have any sanitary objection for its
commercialization in the country of origin.

d. The current Good Manufacturing Practices Certificate, issued by the competent

authority of the manufacturer's country of origin, apostilled or consularized as
appropriate.

6. RE-REGISTRATION OF HEALTH NOTIFICATION

The holder of the Sanitary Notification must submit the application for Re-registration through
the VUE and the payment of the corresponding amount at least ninety (90) days prior to the
expiration date of the Sanitary Notification, and taking into consideration a maximum of one
hundred and eighty (180) days in advance.

6.1. AUTOMATIC RE-ENROLLMENT

The holder of the Health Notification must submit an electronically signed letter, in which he/she
indicates that during the period of validity of the product, the product is not subject to any of the
following situations:

▪ It has not undergone any changes or modifications in its safety or intended use;
▪ It has not been subject to suspension or alert by the Health Authority;

6.2. RE-REGISTRATION WITH TECHNICAL DOCUMENTARY REVIEW

The granted Sanitary Notification may be re-registered upon request made at the Ecuadorian
Single Window (VUE). The re-registration with technical documentary review will be applied for
those products that during its period of validity:

▪ Had been subject to suspension by the health authority.

▪ To file the application within ninety (90) days.

The National Agency of Regulation, Control and Sanitary Surveillance - ARCSA, may:

▪ Analyze the file of the product to be re-registered.

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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OR SERVICES
HOMEOPATHIC MEDICINES

▪ Request any other documentation that ARCSA considers pertinent, since ARCSA may
request in the re-registration process the updating of data and requirements of both the
product and the establishment, in accordance with current regulations.

If you have not requested the re-registration of the Health Notification and the effective date has
expired, i.e., the Health Notification will be in an expired status; you will have to initiate a new
registration process.

7. MODIFICATION OF THE HEALTH NOTIFICATION

7.1. CASES REQUIRING A NEW HEALTH NOTIFICATION

A new Health Notification will be required for homeopathic products or medicines, when the
following changes occur with respect to the homeopathic product and after payment of the
corresponding amount:

a. Change of dilution or volume of the homeopathic strain;

b. Change of pharmaceutical form;
c. Change of therapeutic indications;
d. Change or inclusion of homeopathic strain or mother tincture.

For the requested modification, users must submit all the documentation for a new Sanitary
Notification for national or foreign registration, respectively.

When a new sanitary notification is granted to a product, due to any of the above changes, the
previous Sanitary Notification will be automatically cancelled and will be recorded in the product's
history.

Any change not included in the above detailed list that requires obtaining a new sanitary
notification will be considered as a modification.

7.2. CASES THAT DO NOT REQUIRE A NEW HEALTH NOTIFICATION

A new Health Notification will not be required for homeopathic products in the following cases:

a. Change or inclusion of the nature of the packaging material;

In the case of this modification, the holder of the sanitary notification must present the following
requirements, as long as he/she demonstrates that it does not affect the stability of the product:

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
 EXTERNAL INSTRUCTION CODE IE-B.3.2.1-MH-01
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OR SERVICES
HOMEOPATHIC MEDICINES

• New packaging material specifications;

• Finished product specifications;
• Product stability study of three different batches with the new internal packaging;

b. Change of product name;

In the case of this modification, the holder of the sanitary notification must present:
• Label and package insert format with the new product name in Spanish language, in
clearly legible and indelible characters;
• Document issued by the owner of the product certifying the change of the product
name, such document must be Consularized or Apostilled as the case may be.
(FOREIGN);
• Legalized document issued by the holder of the sanitary notification certifying the
change of its name (NATIONAL).

c. Change of name or company name of manufacturer, product holder, applicant/health

notification holder and packager;

In the case of the modification "change of name or company name of the manufacturer", the
holder of the health notification shall submit:

• Label format with the new name of the manufacturer's company name;
• Documentation issued by the competent authority certifying the change of corporate
name, such document must be Consularized or Apostilled as the case may be.
(FOREIGN);
• Legalized document certifying the change of the manufacturer's company name
(NATIONAL);

In the case of the modification "change of name or company name of the product holder", the
holder of the sanitary notification shall submit:

• Label format with the new company name of the Product Holder;
• Document issued by the competent authority certifying the change of the Product
Holder's company name, it must be Consularized or Apostilled as the case may be
(FOREIGN);
• Legalized document certifying the change of company name of the Product Holder
(NATIONAL).

In the case of the modification "change of name or company name of the applicant/health notification
holder and conditioner", the health notification holder shall submit:

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
 EXTERNAL INSTRUCTION CODE IE-B.3.2.1-MH-01
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OR SERVICES
HOMEOPATHIC MEDICINES

• Label format with the new company name of the Health Notification Holder; Legalized
document certifying the change of company name of the Health Notification Holder
(NATIONAL).

Note 1: To apply for these modifications, the Health Notification of a national homeopathic product
must keep the same RUC number.

d. Change of product holder / health notification holder;

In the case of the modification "Change of Product Holder", the holder of the health notification shall
submit:

• Format of labels with the change of Product Holder;

• Prospectus with the change of Product Holder;
• Documentation issued by the competent authority certifying the change of the
product's owner, such document must be Consularized or Apostilled, as the case may
be (FOREIGNERS).
• Legalized or Consularized or Apostilled document in which the previous holder assigns
the rights to the new holder of the product.
• Legalized or Consularized or Apostilled document in which the new holder authorizes
the holder of the health notification to market the product.
• If FOREIGN, present CLV, including the data of the new owner of the product.

In the case of the modification "Change of the holder of the health notification", the holder of the health
notification shall submit:

• Format of labels with the change of Holder of the sanitary notification;

• Prospectus with the change of Health Notification Holder;
• Legalized document certifying the change of holder of the sanitary notification
(NATIONAL).

e. Change of address, city or country of the applicant/holder of the health notification, of the
holder of the product and conditioner;

The requirements for the applicant's change of address to be submitted are:

• Document notifying the Applicant's change of address;

• Operating Permit showing the new address;
• Format of labels and leaflet (only if change of city is involved).

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
 EXTERNAL INSTRUCTION CODE IE-B.3.2.1-MH-01
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OR SERVICES
HOMEOPATHIC MEDICINES

The requirements for the change of address of the product holder to be submitted are:

a. For Nationals:
• Document notifying the change of address of the Product Holder;

b. For Foreigners:
• Document notifying the change of address of the Product Holder;
• CLV or Apostilled document supporting the change.

f. Change or inclusion of conditioner for finished product:

• GMP certificate or inspection document (clarify according to the time of the standard)
• CLV for foreigners only
• Document notifying the change or inclusion of conditioner.

g. Change, increase or decrease of commercial presentations;

In the case of this modification, the holder of the sanitary notification must present:

• Label format with the new presentation;

• Document indicating that the packaging material is the same as that with which it was
approved.

h. Extension of therapeutic indications, presenting technical and pharmacological supporting

documentation;

• Letter or document detailing the justification for the changes;

• Attach comparative table of new and previous pharmacological information;
• Attach updated pharmacological information;
• Attach the updated prospectus.
• Labels and package insert with the new therapeutic indication for OTC products;

i. Change of principal manufacturer; change or inclusion of alternate manufacturer;

All documents required for a new sanitary notification for domestic or foreign registration
respectively.

j. Brand Change/Inclusion;

Only one mark may be entered per Health Notification:

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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OR SERVICES
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• Label and leaflet format;

• Document issued by the owner of the product certifying the change or inclusion of the
trademark, such document must be Consularized or Apostilled as the case may be.
(FOREIGN);
• Legalized document issued by the owner of the product certifying the change of the
product brand (NATIONAL).

k. Change of Technical Manager

• Document of the Technical Manager's relationship with the applicant company.

l. Change of legal representative

• Document evidencing the appointment of the new legal representative with

acknowledgment of signature before the notary, recorded in the Commercial Registry.

m. Prospectus update

• Letter or document detailing the justification for the changes;

• Attach a comparative table with the old and the new leaflet;
• Attach the updated prospectus;
• Attach pharmacological information (when applicable).

n. Inclusion of physical or digital leaflet

• Attach the prospectus;

• Attach pharmacological information;

o. Change of address or city of the principal or alternate manufacturer

For the case of this modification the holder of the sanitary notification shall submit:

• Certificate of Good Manufacturing Practices (GMP) of the manufacturing laboratory

indicating the new address or city or country and the name and pharmaceutical form, in
case of imported products, duly consularized or apostilled as appropriate;
• Format of labels with change of address, city or country of the main manufacturer, for
domestic and foreign;
• Valid manufacturer's operating permit;
• Leaflet addressed to the user with the manufacturer's change of address;

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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• Finished product specifications;

• CLV indicating the manufacturer's new address or GMP Certificate showing the new
address, apostilled;

p. Change, increase or decrease of excipients that do not affect the stability or bioavailability
specifications of the product.

For the case of this modification the holder of the sanitary notification shall submit:

• Raw material quality specifications;

• Quality specifications of the finished product;
• Product stability study;
• Label Format.

q. Variations in the useful life of the product

In the case of an increase in the shelf life, the holder of the health notification shall submit:

• Quality specifications of the finished product;

• Product stability study;

For the case of shortened shelf life, the holder of the health notification shall submit:

• Technical Justification indicating why the useful life period decreases;

r. Change of capsule size

For the case of this modification the holder of the sanitary notification shall submit:

• Quality specifications of the finished product;

• Justification for change of size or color;
• Stability studies;
• Technical specifications of the capsule.

s. Capsule color change

• Quality specifications of the finished product;

• Justification for change of size or color;
• Stability studies.

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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OR SERVICES
HOMEOPATHIC MEDICINES

t. Change of sales modality

For the case of this modification, the holder of the health notification shall justify the classification
of homeopathic products as OTC with the following requirements:

• That the product has demonstrated efficacy and safety for use in the prevention, relief
of symptoms or signs of mild, easily identifiable diseases;
• That they have a wide safety range, so that the voluntary or involuntary administration
of doses higher than those recommended does not represent a serious danger to the
patient's health;
• That they have a wide dosage range, which can be adapted to the age and weight of
the patient;
• That their use does not generate tolerance or dependence and that they are not susceptible to
abuse;
• That when used as directed, they do not mask serious illnesses or delay diagnosis and
treatment of a condition requiring medical attention;
• That its use is safe in all age groups of the population;
• The dosage forms are for oral (O.V.) or topical administration, and not for intravenous
(IV) or intramuscular (IM) administration.
• That adverse reaction reports have not increased during the marketing period.

u. Updating internal/external labels

• Letter or document, signed by the technical representative, detailing the changes;

• Attach comparative chart of the old label vs. the changes of the new label;
• Attach updated internal and external labels

v. Batch Code Interpretation or Batch Coding System Maintenance

• Document justifying the change in the interpretation or batch coding system issued by
the manufacturer, with examples;
• Document stating the new code interpretation procedure, or the structuring of your
batch coding system, signed by the technical representative.

w. Extension in the description of the dosage form (when clarifying or extending the
description) Example: capsules with green cap and body, proposed capsules with green cap
and body and white powder inside)

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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OR SERVICES
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• Justification document detailing the requested extension;

• Finished product specifications.

x. Applicant's change of address

• Document notifying the Applicant's change of address;

• Operating Permit showing the new address;
• Format of labels and leaflet (only if change of city is involved).

y. Change of address of the product holder

For Nationals:

• Document notifying the change of address of the Product Holder; For

Foreigners:

• Document notifying the change of address of the Product Holder;

• CLV or Apostilled document supporting the change.

z. Change in the description of the commercial presentation, medical sample (when

clarifying or extending the description on the form)

• Document justifying the details of the change.

aa. Inclusion of box or external packaging

• Material specifications of the outer packaging;

• Label format.

bb. Inclusion of shrink wrap

In case the shrink-wrap is placed in the inner packaging:

• Document justifying the reason for the change;

• CLV (in case of being a foreigner) apostilled;
• Packaging Material Specifications;
• Stability study.

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
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OR SERVICES
HOMEOPATHIC MEDICINES

In case the shrink-wrap is placed in the outer packaging:

• Document justifying the reason for the change;

• CLV (in case of being a foreigner) apostilled;
• Packaging Material Specifications.

cc. Change in the nature of the inner container cover

• Document justifying the reason for the change;

• Packaging material specifications;
• Stability study.

dd. Change of cover color

• Document justifying the reason for the change;

• Packaging material specifications;
• Stability study (when the product is in direct contact with the cap);
• Technical Specifications of the Finished Product.

ee. Changes in the manufacturing process

• Document justifying in detail the reasons for the change.

• Present manufacturing process.
• Attach comparative table of the change of the current and the new manufacturing
process;
• Certificate of Analysis of Finished Product.

ff. Increase or decrease in the size or dimensions of the internal container

• Document notifying the increase or decrease of the primary container;

• Certificate of Analysis of Finished Product;
• Packaging material specifications;
• Stability study (when applicable).

gg. Elimination of internal packaging of commercial presentations (when presenting more than
one package)

• Document notifying the elimination.

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
 EXTERNAL INSTRUCTION CODE IE-B.3.2.1-MH-01
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OR SERVICES
HOMEOPATHIC MEDICINES

hh. Updating of internal and/or external packaging specifications

• Document notifying the update;

• Attach table comparing the change in the current and previous Specification;
• Specifications of the updated packaging material.

ii. Change in the description of the dosage form (e.g. from oblong to round, engraved, beveled
or colored tablet)

Shape Type Change (Example: oblong to round)

• Document justifying the change;

• Finished product specifications;
• Certificate of Analysis of Finished Product; Change in

shape (e.g.: engraved, beveled, smooth or grooved)

• Document justifying the change;

• Finished product specifications;
• Certificate of Analysis of Finished Product;

Color Change

• Document justifying the change;

• Qualitative-quantitative formula;
• If foreign CLV apostilled with the new formula;
• Attach the manufacturing process;
• Stability studies;
• Certificate of analysis of excipients;
• Certificate of Analysis of Finished Product;
• Finished product specifications;
• Prospectus

jj. Inclusion of mode of administration (example: IV "intravenous" to IM "intramuscular").

• Document justifying the inclusion of the route of administration;

• Internal and external labels;
• Pharmacological information;
• Clinical studies;
THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
 EXTERNAL INSTRUCTION CODE IE-B.3.2.1-MH-01
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OR SERVICES
HOMEOPATHIC MEDICINES

• Prospectus.

kk. Inclusion of safety seals on outer packaging

• Document justifying the change;

• Attach design of the seal to be included;
• Security seal specifications.

ll. Change of exporting country

• Document justifying the reason for the change;

• Apostilled CLV.

mm. Change or addition of raw material supplier

• Technical specifications of the new raw material;

• Authorization document by the National Agrarian Entity (national - CBD).

nn. Any other modification not mentioned above must be notified to ARCSA, who will
authorize or deny it, after the corresponding analysis;

• Documents requested by the Agency in accordance with the modification being requested.

8. ANNEXES
8.1. Annex 1: Signed letter detailing the list of documents attached to the application.

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
 EXTERNAL INSTRUCTION CODE IE-B.3.2.1-MH-01
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OR SERVICES
HOMEOPATHIC MEDICINES

Annex 1

SIGNED LETTER FORMAT DETAILING THE LIST OF DOCUMENTS ATTACHED TO THE

APPLICATION

DIRECTOR'S NAME
Technical Direction of Sanitary Registration, Mandatory Sanitary Notification and

Authorizations In his office.

Dear Sir or Madam:

Hereby, I (name of the legal representative) with identification number (number), with
fingerprint (number) as legal representative of (name of the establishment) and I (name of
the technical representative) with identification number (number), with fingerprint
(number) as technical representative of the homeopathic product or medicine (name of
the homeopathic product or medicine), I hereby submit this letter detailing the documents
reviewed and attached to the application, in accordance with Resolution ARCSA-DE-2023-
012-AKRG, by which the Technical Sanitary Regulations Substitute for Sanitary
Notification of Homeopathic Products or Medicines, and Good Manufacturing Practices
for Pharmaceutical Laboratories are issued.

List of documents
Justification of homeopathic therapeutic
use, contraindications,
warnings, interactions, effects, etc.
collaterals and precautions for use.
Project of external and internal labels.
Prospectus
Modality of Sale.
Product stability studies
homeopathic.
Manufacturing Process.
Scientific name of the stock(s) or mother
tincture(s).

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.
 EXTERNAL INSTRUCTION CODE IE-B.3.2.1-MH-01
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OR SERVICES
HOMEOPATHIC MEDICINES

Strain identification certificate

homeopathic and its origin.
Certificate fromGood Good
Manufacturing Practices
Manufacturing Practices.
Specifications from quality from of
raw materials.
Product quality specifications
finished.
Technical specifications of primary and
secondary packaging material.
Batch code interpretation.
Analytical methodology used for
finished product analysis.
Power of Attorney duly
legalized o
apostilled.
Certificate of free sale.

I declare that all information provided is true, complete, correct, and can be verified.

LIABILITY COMPANIES

(Name of the technical representative) (Name of the legal

representative)(Identity number) (Identity number)

THE NATIONAL AGENCY FOR REGULATION, CONTROL AND SANITARY SURVEILLANCE RESERVES THE RIGHT TO THIS DOCUMENT, WHICH SHOULD NOT BE USED FOR ANY PURPOSE
OTHER THAN THAT FORESEEN IN IT, PRINTED OR PHOTOCOPIED DOCUMENTS ARE UNCONTROLLED COPIES, ALWAYS CHECK WITH THE LATEST VERSION IN FORCE IN THE
INSTITUTIONAL REPOSITORY.