南美洲国家-药品注册要求

Requirements to get registration in Paraguay

a) Legal Documents

1. GMP certificate issued by China FDA, attested by Paraguay’s embassy (or Argentinian embassy).

2. GMP certificate issued by other authorities, attested by Paraguay’s embassy.

3. Manufacturing License, attested by Paraguay’s embassy.

4. Manufacturing Agreement, signing and sealing by manufacturer and attested by Paraguay’s embassy.

5. Letter of Representation, signing and sealing by manufacturer and attested by Paraguay’s embassy.

6. Quli-Quantitative Formula, signing and sealing by manufacturer and attested by Paraguay’s embassy.

7. FSC, attested by Paraguay’s embassy.

b) Technical Dossier

1. Method of Analysis.

2. Validation of Analytical Methods.

3. Stability study, climatic zone IV A.

Requirements to get registration in Costa Rica

1. Power of Attorney (issued by distributor)/or Loan License Agreement. This document should be attested/legalized by Costa Rican’s embassy or through Apostille.

2. FSC or COPP attested by Costa Rican’s embassy. Please including Quali-Quantitative Formula.

3. GMP attested by Costa Rican’s embassy (if make mention in FSC/COPP, then will not require, unless if the drug are classified as ONCOLOGICAL, HORMONAL, B-LAC**IC of BIOLOGICALS).

4. Quali-Quantitative Formula, declare active ingredient/excipient per tablet, per 100g, per 100ml. Should declare if use any organic solvents during the process of manufacturing.

5. Certificate of Analyses, should signed IN original.

6. Stability Data zone IV, 3 batches commercial or pilot scale batch (30±2°C, HR 65±5% in long terms, 40±2°C, HR 75±5% for accelerated studies). this should be attested/CR legalizated by CR embassy or though Apostille.

7. Monograph, include toxicology and pharmacology information.

8. Primary and Secondary Artwork in editable .al, .cdr files.

9. Finished Product Specification.

10. Method of Analyses of finish product.

11. Validation of Method Analyses, will not require if is USP-BP pharmacopeical, but is necessary to present Accuracy and Precision even is USP-BP.

12. Microbiological Validation (applies to liquid forms)

13. Samples of finish product: 1 sample.

非常棒！
谢谢分享！