By: Roxana Bermúdez, Olga Torres.
Registration
- Module I (administrative information), Annex A of the Standard
Submit the documentation supporting the application for registration. Take into consideration that additional data is mentioned in comparison with the chemical synthesis products
a) Provide data of the manufacturer involved in the different stages of production (active ingredient, bulk, finished product, diluent in the case of lyophilized products, others). These data are: name, address, email and telephone.
b) Legal documentation:
-GMP of all laboratories involved in the whole production process. The
The certificate must indicate for which procedure the establishment is authorized.
-Certificate of patents of invention (if applicable).
-Certificate of test data (if applicable).
- Module II (summaries), annex B of the standard
Submit the summary of the chemical, pharmaceutical and biological quality data of the pre-clinical and clinical data submitted in Modules II, IV and V. The summaries should be objective and refer to the tables included in modules II, IV and V.
- Module III quality information, Annex C of the standard.
It covers the chemical, pharmaceutical and biological data of the development, manufacturing process, analytical certificates of characterization and properties, quality control, specifications and stability of the active ingredient(s), as well as of the finished product.
- Module IV pre-clinical test reports, annex D of the standard
Tests of representative batches of the product proposed for the initial clinical studies according to the ICH S6 Biotechnological Products guideline and other applicable guidelines for these types of products.
- Module V Clinical Trial Reports, Annex E of the standard
They should be conducted according to the principles described in the WHO Guidelines for Good Clinical Practice (GCP) for trials with pharmaceutical products in force and other applicable guidelines. The studies must use the formulation of the drug under evaluation, otherwise additional evidence of comparability will be required.
Renewal of Registrations
In the case that the laboratories maintain the information updated, according to the approved Risk Management Plan, it will not be necessary to submit the information described in modules 4 and 5.
Post-registration changes
-Modifications must follow the requirements requested in Annex VI of the standard.
-The ARN reserves the right to request any additional documentation it deems necessary for the evaluation of the submitted change.
-In the case of modifications that are not contemplated in the standard, the applicant must submit the technical/legal documentation supporting the change and the ARN will analyze the case.
Causes for cancellation of the sanitary registration
1. When the owner of the registration does not proceed with the renewal application according to the requirements established in the present rule.
2. When it is demonstrated through post-marketing studies or others that the product does not comply in quality, safety and/or effectiveness.
3. In case of national and international alerts on the risk of the product.
4. When the owner of the registration requests the cancellation of the registration.
Causes for cancellation of the blood product batch release certificate
The Pharmacy Directorate will cancel the batch release certificate issued by means of a written communication addressed to the interested party, stating that such certificate has been cancelled and that it cannot be marketed or continue to be marketed in the following cases:
1. when inconveniences arise, as in the case of adverse reaction report.
2. Sanitary measures because of inspection, surveillance, and control activities.
3. Worldwide sanitary alert that results in the withdrawal of a lot from the market.
4. When the manufacturing laboratory informs that they will no longer manufacture or import the previously released batch.
Published in La Gaceta Diario Oficial on November 12, 2020, in the practice of the evaluations of the submitted procedures, the standard is being applied in its entirety since February of this year.