Suchergebnisse
Suchergebnisse:
The EudraGMDP database is the Community database on manufacturing, import and wholesale-distribution authorisations, and good manufacturing-practice (GMP) and good-distribution-practice (GDP) certificates. A public version of the database has been available since 2011, which allows public access to the information in the database that is not of ...
- Eudra GMP - Public Layout
GMP Certificates are to be entered into EudraGMDP, as...
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EudraGMDP database. Guidance on good manufacturing practice...
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EudraLex - EU Legislation. The European elections in 2024...
- Eudra GMP - Public Layout
Eudra GMP - Public Layout. Welcome to EudraGMDP. EudraGMDP is the name for the Union database referred to in article 111 (6) of Directive 2001/83/EC as amended, and article 91 of Regulation (EU) 2019/6. It contains the following information: Manufacturing and import authorisations. Good Manufacturing Practice (GMP) certificates.
Due to the restrictions caused by COVID-19, the period of validity of GMP and GDP certificates issued by EEA authorities is automatically extended until the end of 2024, except where clarifying remarks in the document state otherwise. Manufacturers, importers and distributors must continue to comply with GMP/GDP and all other legal obligations. On-site inspections are now being conducted and ...
8. Okt. 2003 · Part IV - GMP requirements for Advanced Therapy Medicinal Products. Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products; Other documents related to GMP and GDP. Compilation of Union Procedures on Inspections and Exchange of Information
