Medicines and Healthcare products Regulatory Agency

Certificate No: UK WDA(H) 53886 Insp GDP 53886/19545201-0001

CERTIFICATE OF GDP COMPLIANCE OF A WHOLESALE DISTRIBUTOR

Issued following an inspection in accordance with Regulation 331 (4) (b) of the Human Medicines Regulations 2012
The wholesale distributor : OPELLA HEALTHCARE UK LIMITED
Site address : OPELLA HEALTHCARE UK LIMITED, 410 THAMES VALLEY PARK DRIVE, READING, RG6 1PT, UNITED KINGDOM

 

Has been inspected under the national inspection programme in connection with authorisation number UK WDA(H) 53886 Insp GDP 53886/19545201-0001 in accordance with regulation 18 of the Human Medicines Regulations 2012

From the knowledge gained during inspection of this wholesale distributor, the latest of which was conducted on 07/09/2021, it is considered that it complies with the principles of good distribution practice requirements referred to in regulation C17 of the Human Medicines Regulations 2012

This certificate reflects the status of the premises at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than five years have elapsed since the date of that inspection. However this period of validity may be reduced using regulatory risk management principles, by an entry in the Restrictions or Clarifying Remarks field.

This certificate is valid only when presented with all pages.

The authenticity of this certificate may be verified in MHRA-GMDP. If it does not appear please contact the issuing authority.

Any restrictions or clarifying remarks related to the scope of this certificate(For All Users):

In accordance with the MHRA risk based inspection procedures this site, which was the subject of a new wholesale distribution authorisation application, will be re-inspected within 24 months of the initial inspection. This certificate should not be relied upon to reflect the compliance status if more than 24 months have elapsed since the date of that initial inspection.