Albania Drug Registration Process

Documents Required for Product Registration in Albania

The specific documents required for the registration of medicinal products with the Agency for Medicinal Products and Medical Devices (AMPMD) in Albania can vary based on the type of product, its classification, and the regulatory requirements in place. However, in general, the following documents are commonly requested during the registration process:

1.  Application Form: A completed application form provides essential details about the medicinal product, its manufacturer, and other relevant information.
2. Pharmaceutical Documentation: Information on the composition of the medicinal product, including active ingredients and excipients. Manufacturing and control data, including details about the production process, quality control methods, and specifications.
3. Non-Clinical Data: Non-clinical study reports that demonstrate the safety and pharmacological properties of the medicinal product.
4. Clinical Data: Clinical trial data (if applicable) demonstrating the safety, efficacy, and quality of the medicinal product. Summary of clinical trial results.
5. Quality Risk Management Documentation: Documentation related to quality risk management, which assesses potential risks and outlines strategies for mitigating those risks.
6. Labeling and Packaging Information: Proposed labeling and packaging information, including the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).
7.  Good Manufacturing Practices (GMP) Certificate: A Good Manufacturing Practices certificate for the manufacturing site(s) of the medicinal product.
8.  Declaration of Conformity: A declaration confirming that the medicinal product complies with relevant regulatory requirements.
9.  Power of Attorney: If applicable, a power of attorney or authorization allowing a representative to act on behalf of the applicant.
10. Fees: Payment of the required registration fees.