Modification to marketing authorization, medical devices, medicines, drugs, plant nutrients, Mexico | Regisan, consulting on regulatory issues in health.

Modification to marketing authorization

We facilitate the integration of the documents required for the submission of complete and adequate information. We make any change, eg. changes in a manufacturing site, packing material, equivalences of Mexico-US Standard (FDA) or Mexico-Canada in the case of Medical Devices; and amendments, closure of centres, etc.

To know more about how you might know if you need a bioequivalence study to submit your modification based on whether it is a generic medicine and what are the requirements for its submission according to its pharmaceutical form, we mention the following criteria issued by Cofepris:

Criteria to determine the type of interchangeability test to consider a medicine as generic:

I. Medicines that do not require testing for dissolution or bioequivalence are:
a. Aqueous solutions for parenteral use;
b. Oral solutions free of known excipients that modify the pharmacokinetic parameters;
c. Gases;
d. Topical medications for non-systemic use and whose absorption does not represent a risk;
e. Medicines for inhalation in aqueous solution, and
F. Medicines for inhalation in suspension and which particle size is demonstrably equal to that of the innovator.
Regarding the medicines appearing in the Relation of pharmaceutical specialities susceptible to be included in the Generic Medicines Catalog, the tests that must be applied are determined and the designated reference product is indicated. The interchangeability test referred to in subsection (I) is identified with the letter "A".
II. All solid oral medicines, with the exception of those that are in one or more of the cases indicated in the following section, must undergo dissolution profile tests. They can exempt the bioequivalence test those drugs that, without being included in any of the above assumptions, demonstrate experimentally or by using equivalence published in indexed sources, which have a high solubility. If this is the case, tests of the dissolution profile should be carried out in three different pH (1, 4.5 and 6.8). If the dissolution profiles are not satisfactory, the bioequivalence test can always be performed, which is considered the gold standard.
Regarding the medicines appearing in the Relation of pharmaceutical specialities susceptible to be included in the Generic Medicines Catalog, the tests that must be applied are determined and the designated reference product is indicated. The interchangeability test referred to in subsection (II) is identified with the letter "B".
III. To determine if medication must be submitted to Bioequivalence, the following criteria will be followed:

CRITERION 1: PHARMACEUTICAL FORM
i. All oral pharmaceutical forms of immediate release
ii. All pharmaceutical forms of modified release
iii. All non-oral pharmaceutical forms of systematic action (rectal, vaginal, transdermal)
iv. Pharmaceutical forms in suspension and emulsion
v. Pharmaceutical forms with a combination of assets

CRITERION 2: STRICT THERAPEUTIC MARGIN
i. All those medicines in which the relationship between therapeutic concentration and toxic concentration is very close must be considered, as well as all those medicines that have toxic effects at their therapeutic concentrations.
Health Authorization Committee
Generic Drugs Program

CRITERION 3: THERAPEUTIC GROUP
i. All those medicines that belong to the following therapeutic groups due to the need to maintain stable plasma concentrations and to be used for the treatment of serious ailments:
1. Antibiotics
2. Hormonal
3. Antineoplastic agents
4. Cardiotonic agents
5. Antiepileptics
6. Immunosuppressants
7. Virostatic agents
8. Hypoglycemic agents

CRITERION 4: PHARMACOKINETIC
i. Drugs with non-linear pharmacokinetics
ii. Drugs with known low absorption
iii. Drugs that have a high first pass metabolism (greater than 70%)
iv. Drugs with combined metabolic pathways
v. Drugs without information on their pharmacokinetics

CRITERION 5: PHYSICOCHEMICAL
i. Drugs with low solubility
ii. Drugs with polymorphism
iii. Highly unstable drugs
All drugs that are in any of the above assumptions must present a Bioequivalence test for inclusion in the Generic Drug Catalog.
Regarding the medicines appearing in the Relation of pharmaceutical specialities susceptible to be included in the Generic Medicines Catalog, the tests that must be applied are determined and the designated reference product is indicated. The interchangeability test referred to in subsection (III) is identified with the letter "C".
If there is not enough information on a medicine properly accredited in international publications, the Bioequivalence test must be performed in all cases, even if it is not in any of the previous cases.
The tests to demonstrate the interchangeability of generic drugs must be carried out as established in the Official Mexican Standard NOM-177-SSA1-1998, which establishes the tests and procedures to demonstrate that a drug is interchangeable. Requirements that the authorized third parties that carry out the test must comply, in force.

Requires marketing authorization

Medical devices

Class I, II and III

Requires marketing authorization

Medicines

Allopathic, herbal, homoeopathic, vitamins, orphan.

Requires marketing authorization

Plant nutrients

Substances involved in the development of plants.