Requirements for Medicines Registration in the Americas. Washington, DC : PAHO, 2013. (Pan American Network on Drug Regulatory Harmonization - PANDRH, Technical Document n.10).
1. Pharmaceutical Services - legislation & jurisprudence. 2. Pharmacy Administration. 3. Legislation, Pharmacy. 4. Research Report. 5. Americas. I. Title.
National standards shall be established in keeping with each country's legislation, and whenever pertinent, appropriate changes will be made in order to adhere as much as possible to these requirements.
In keeping with the format found in other similar guidelines of the Pan American Network on Drug Regulatory Harmonization (PANDRH), this document consists of four (4) modules and two (2) annexes.
- Module 1: Administrative and legal information.
- Module 2: Quality information.
- Module 3: Nonclinical reports.
- Module 4: Clinical reports.
- Annex 1: Summary of Product Characteristics (SPC).
- Annex 2: Information on labelling and package inserts.