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Demystifying Pharmaceutical Registration in Albania: Your Ultimate Guide to Medicine, Drug, and OTC Product Approval Processes

MoH: The Ministry of Health and Social Protection.

MoH website: https://shendetesia.gov.al

Regulatory Authority: National Agency for Medicines and Medical Devices (AKPBM)

Link for Regulatory Authority: https://akbpm.gov.al/

Medicine/Drug/OTC/Pharmaceutical Registration in Albania

The Agency for Medicinal Products and Medical Devices (AMPMD) is responsible for overseeing the drug registration process in Albania.

Here is a general outline of the drug registration process:

1. Preparation of Documentation

Collect and prepare all necessary documentation, including but not limited to:

1. 1. Pharmaceutical documentation (composition, manufacturing, and control data)

1. 2. Non-clinical and clinical data

1.3. Information on packaging and labeling

1.4. Summary of product characteristics (SmPC) and patient information leaflet (PIL)

1.5. Quality risk management documentation

2. Application Submission

Submit the completed application and required documents to the AMPMD.

3. Review and Evaluation

The regulatory authority reviews the submitted documentation to assess the safety, efficacy, and quality of the medicinal product. An evaluation committee may be involved in the assessment process.

4. Quality Control Inspection

Conduct a quality control inspection, which may include an inspection of the manufacturing facilities, to ensure compliance with good manufacturing practices (GMP).

5. Clinical Trial Data Review

If applicable, review clinical trial data to support the safety and efficacy of the medicinal product.

6. Labeling and Packaging Review

Evaluate the proposed labeling and packaging to ensure compliance with regulatory requirements.

7. Decision and Approval

Based on the review, the regulatory authority decides whether to approve the drug registration. If approved, a marketing authorization is issued.

8. Post-Market Surveillance

Implement post-market surveillance measures to monitor the safety and effectiveness of the drug once it is on the market.

Documents required for Pharmaceutical 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 GMP 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.

License Validity

5 years

FSC Required

yes

Local Authorised Representative Required

Yes

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