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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