Registration of Medicines

This Section is intended to provide guidance for companies operating in the medical drugs area. It contains directions on how to submit applications for registering drugs, modifications, exemptions and renewals. It also provides information about the documentation required and instructions on how to complete the application forms.

Procedures Manual for Registration of New Medicines

Documents required for registration of a new product

This is applicable to those products falling within the following categories:

1. A product resulting from:

a) An alteration in the concentration of active substance or of its pharmacokinetic properties
b) an active substance not registered for the purpose for which it was intended
c) withdrawal of the active component of a product already registered
d) substitution of the active component of a product already registered.

2. A product resulting from new molecular entities

3. A new salt, despite the corresponding molecular body having already been authorized.

4. Two or more active unregistered substances , combined in the same product.

List of documents required for registration

Document 01: Application forms FP1 and FP2, completed, as appropriate, in original plus one copy.

Document 02: Receipt (original plus one copy) proving payment of fee based on the Government Tariff, duly authenticated and/or stamped.

Document 03 : Copy of the published announcement confirming award of Company Operating License.

Document 04: Receipt proving registration of the product, together with its original printed inserts (directions for use, etc), approved in the country of origin and in other countries if applicable.

Document 05; Report of Therapeutic Testing, drafted and submitted in accordance with the sequence required according to Resolution 01/88 of 5/1/89, of the National Health Council, paying particular attention to the product's bioavailability and toxicity.

Document 06: Technical Report on the product containing the following items:

1. General data:

a) Pharmaceutical form in which presented;

b) Formula, indicating the basic components per dose required or, if possible, per gram, m/l or standard international unit of measure;

(c) directions on how to administer/use product;

(d) main features, purpose or use to which product is to be put;

( e) complementary therapeutic indications;

(f) contraindications, side effects, adverse reactions;

(g) restrictions or precautions that need to be considered;

(h) expiry date;

( i) storage precautions;

( j) instruction for use, if appropriate.

2. Pharmacodynamics:

(a )How it works;

(b) Dosage (maximum and minimum doses);

(c) Justification for recommended doses.

3. Production and Quality Control:

(a) the complete formula of the preparation, with all its components specified by the technical names, equivalent names and synonyms in accordance with Brazilian Common Terminology (DCB), with the amounts of each substance expressed in metric units of measurement or in standard units, also denoting the substances used as a vehicle or excipient;

(b) the production process, with a concise description of the various procedures to be carried out;

(c) descriptive report referring to quality control, based upon the active components of the formula of the product, together with stability and physiochemical tests on the raw material and the finished product;

(d) the tolerance limits for the tests and dosages, in the absence of official norms;

(e) the code or method used by the company for identification of the shipment groups or batches of the product;

(f) report containing the technical data indicating no physical or chemical incompatibility between the packaging to be used and the components of the formula of the product;


(g) storage and transport precautions to be taken.

4 .Complementary data:

a) mention the registration of the substance or the basic components of the formula in the pharmacopoeia, in official publications dealing with pharmaceutical standards and/or in journals of scientific repute;

b) enclose the bibliography on the product and the relevant literature, and in the event of the product being of foreign origin, a full translation from the original language. DETEN/SVS can request such information to be supplied (in duplicate for retention in its records) which it judges necessary for assessing the scientific documentation;

c) if the product contains narcotic, hypnotic or barbituric substances, provide evidence indicating that the special provisions covering such substances have been complied with;

d) demonstrate the advantages of the proposed formula, with a justification from a clinical standpoint;

e) other details that are appropriate or necessary, including those that elucidate causes and effects, in order to enable the health authorities to come to a correct conclusion about the product.

Document 07: Examples of the labels, printed inserts, typed in duplicate.

Document 08: Copy of the Operating License of the Company and/or its Health Permit.

Document 09: Written evidence that the manufacturing plant is overseen by the properly qualified responsible Technical Officer.

Additional documents required:

In addition to the aforementioned documents, and depending on the product to be registered, the following procedure must be followed, in this order:

Document A
Copy, photocopy or transcript of the registered permit in the country of origin in the case of drugs, medicines or pharmaceutical inputs of foreign origin.

Document B
A report containing the recommendations, contra-indications and warnings presented with the application for registration in the country of origin signed by the Technical Officer responsible for the product to be registered.

Document C

The Good Practices Manual used by the company.

O bservations:

a) All the documentation must be signed by the Legal Representative of the company in question

b) Documentation referring to the technical aspects of the application must in addition be signed by the Technical Officer responsible.

c) The documents which have already been the subject of the Health Permit authorization do not need to be submitted.

Documents required for Registration of a Similar Drug

List of documents required for processing registration of the product:

1. The documents required are the same as those required for registering a new product, with the exception of Document 5 (therapeutic test report). This should be replaced by a report that must be drawn up in accordance with Resolution 4/78 of the Medicines Technical Chamber, of the National Health Council, the requirements of which are set out below:

POINTS TO BE TAKEN INTO ACCOUNT IN DRAWING UP THE REPORT (RN 4/78 OF CTM/CNS)

a) A "similar" drug is that which contains the same therapeutically active substance or substances as the basis of its formula and which possesses dosage directions similar to the medicine which is already registered in Brazil.

b) In cases where the "similar" drug submitted for registration differs from the original medicine, whether in its pharmaceutical form, its dosage, its method of administration and side effects, it is essential to submit complementary descriptive information containing documented scientific proof in accordance with the instructions for registering a new product in Brazil.

c) Alteration of the registration of a "similar" drug which has already been granted, with respect to any of the conditions mentioned in (b) above, is also subject to the same requirements as set forth in that same item.
NOTE: The Brazilian Sanitary Surveillance Agency may request production of the latest scientific data for the "similar" drug (registered or in the process of being registered) whenever considered appropriate.

2. The applicant is required to draw attention to the similar product by citing its name and its respective permit number.
Observations:

a) All the documents must be signed by the Legal Representative of the company concerned.

b) In addition, documentation referring to the technical aspects of the application must be signed by the responsible Technical Officer.