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Glossary of Pharmaceutical Regulatory Terms

If you are not familiar with the European terminology for pharmaceutical regulatory and drug control issues, you may find this glossary a useful tool for better orientation.

PIL

Package Information Leaflet

SOP

Standard Operating Procedure

QRD

Quality Recognition Document

SmPC

Summary of Product Characteristics

MRP/DCP

Mutual Recognition Procedure / Decentralized Procedure

CTD

Common Technical Document

CMS

Concerned Member State

RMS

Reference Member State

MA Holder

Marketing Authorization Holder

 

 

 

 

 

 

 


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