In the current context of world pandemic, the production and commercialization of pharmaceutical products has increased considerably, for this reason we decided to provide our clients with basic information about the sanitary registration of pharmaceutical products in Bolivia.
The State Agency of Medicines and Health (AGEMED) is the authority in charge of making the corresponding sanitary registrations of all types of pharmaceuticals products in Bolivia. This agency has the capacity to regulate, regulate, monitor, control and promote the rational use of medicines. Through policies that propose two main pillars: The National System for the Surveillance and Control of Medicines and the Single National Supply System, systems that together make it possible to achieve the general objective of the National Medicines Policy.
WHICH PRODUCTS ARE SUBJECT TO PHARMACEUTICAL SANITARY REGISTRATION IN AGEMED?
- a) Generic drugs (International Nonproprietary Name – INN);
- b) Brand name drugs;
- c) Homeopathic medications;
- d) Products of vegetable, animal or mineral origin having medicinal properties (with specific standard;
- d) Products of plant, animal or mineral origin having medicinal properties (with specific standard);
- e) Special medicines, biologicals (specific regulation), blood derivatives, dietetic, dental, radio-pharmaceuticals; f) Vaccines and biologicals (specific regulation), blood products, dietetic, dental, radio-pharmaceuticals;
- f) Vaccines and biologicals (specific regulation);
- g) Cosmetics (specific regulations);
- h) Medical devices (specific regulations);
- i) Diagnostic and clinical laboratory reagents (specific regulation); and;
- j) Handcrafted traditional natural products (specific regulation).
WHAT ARE THE REQUIREMENTS FOR THE SANITARY REGISTRATION OF MEDICINES IN AGEMED?
Submission of the application form for registration and quality control of medicines (DINAMED Form 005).
Presentation of legal-administrative documentation of the companies:
- Photocopy of Ministerial or Secretarial Resolution
- Photocopy of Company Certificate in force
- General License and Manufacturer Information
- Format for Clarification of Particularities
Presentation of general product documentation
- Technical Director of Pharmaceutical Regent Certificate
- Good Manufacturing Practices Certificate
- Contract Manufacturing or Quality Control by third parties
- Certificate of Pharmaceutical Products Subject to International Trade
- Photocopy of previous Sanitary Registration
- Photocopy of Customs Clearance certificate
Presentation of technical information of the active ingredient
- Photocopy of the certificate of analysis of the raw material.
- Generic name and anatomic-therapeutic chemical classification.
- Chemical name, structural formula, molecular formula and molecular weight.
- Physical and chemical characteristics of the active ingredient.
- Organoleptic characteristics.
- Other.
Presentation of technical information of the finished product
- Galenic development of the product
- Qualia-Quantitative Formula
- Photocopy of the Certificate of Analysis of the finished product.
- Photocopy of the Quality Control Certificate
- Others.
Presentation of biopharmaceutical technical documentation
- Bioavailability Studies
- Bioequivalence Studies
Presentation of labels, tags, inserts or leaflets
- Labels, tags and cases
- Inserts or leaflets
Pharmacological evaluation presentation
- DINAMED qualification request form, form 007
- Efficacy and safety qualification form DINAMED form. 019
- Others
Sample presentation
Payment for service.
Maintenance of the Health Registration Number
Re-registration of a drug not marketed: Any pharmaceutical product that was not marketed during the 5 years of validity of the Sanitary Registration of drugs in AGEMED, in case of re-registration, the payment corresponding to a registration must be cancelled, maintaining the number that was initially assigned to it.
VALIDITY OF THE SANITARY REGISTRATION
With the exception of cosmetics, the Sanitary Registration of medicines in AGEMED is valid for five years from the date of issuance, with the following subsequent processes:
Re-registration Process: Any re-registration request submitted before the 5 years of validity of the Registration or up to 30 working days after, will be considered as a re-registration process, being valid the Sanitary Registration for its manufacture, importation, distribution and commercialization, as long as it is subject to technical specifications and Pharmacological Standards in force.
Commercialization with expired Sanitary Registration: In some cases, the commercialization of a medicine whose Sanitary Registration has expired will be allowed, provided that one of the following situations is demonstrated:
- To have filed the Request for Qualification and documentation corresponding to the re-registration of the product before or up to 30 working days after its expiration.
- b) When the customs clearance certificate has been granted or the commercialization of the batch or batches has been reported before the expiration of the Sanitary Registration of medicines in AGEMED.
- c) In accordance with the aforementioned points, medicines may be marketed with the printing of the previous Health Registration number, until the stock already printed is exhausted.