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Uk Mhra Gmp
•MERCK SHARP & DOHME (UK) LIMITED•April 25, 2025

MERCK SHARP & DOHME (UK) LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 53095 Insp IMP 53095/19534521-0007[I]

Record Details

This Uk Mhra Gmp record concerns MERCK SHARP & DOHME (UK) LIMITED, with an inspection on April 25, 2025, issued by the MHRA, covering drugs.

Company
MERCK SHARP & DOHME (UK) LIMITED
Compliance status
GMPC
Certificate type
IMP
Inspection date
April 25, 2025
Issued
April 25, 2025
MIA number
UK MIA(IMP) 53095
Site address
120 MOORGATE, LONDON, EC2M 6UR, UNITED KINGDOM
Country
UNITED KINGDOM
Products
Human Investigational Medicinal Products
Manufacturing operations
1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Investigational Medicinal Products [ 1.1.3 ] Batch certification [ 1.2 ] Non-sterile investigational medicinal products [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.2 ] Batch certification [ 1.3.2.2 ] Immunological products [ 1.3.2.4 ] Gene therapy products [ 1.3.2.5 ] Biotechnology products 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.2 ] Batch certification of imported medicinal products [ 2.2.1 ] Sterile Products [ 2.2.1.1 ] Aseptically prepared [ 2.2.1.2 ] Terminally sterilised [ 2.2.2 ] Non-sterile products [ 2.2.3 ] Biological medicinal products [ 2.2.3.2 ] Immunological products [ 2.2.3.4 ] Gene therapy products [ 2.2.3.5 ] Biotechnology products [ 2.3 ] Other Importation Activities [ 2.3.4 ] OtherImportation of QP certified IMP's from a country on the approved country for import list
Restrictions
This certificate is issued based on a desk-based assessment of GMP compliance information provided by the manufacturer and should be used in combination with the relevant authorisation/registration. A risk-based site inspection programme remains in force.
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ID · 52fc26b5-1790-4983-8164-98af73e947f4

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