Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 15632 |
|---|---|
| 2: Name of authorisation holder | PHARMAPAC (UK) LIMITED |
| 3: Address(es) of manufacturing site(s) |
PHARMAPAC (UK) LIMITED, UNITS 20 TO 24 AND 29 AND 30, VALLEY ROAD BUSINESS PARK, BIRKENHEAD, CH41 7EL, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | PHARMAPAC (UK) LIMITED, UNIT 22, VALLEY ROAD BUSINESS PARK, BIDSTON, WIRRAL, MERSEYSIDE, CH41 7EL, UNITED KINGDOM |
| 5: Scope of authorisation and dosage forms | ANNEX 1 and/ or ANNEX 2 |
| 6: Legal Basis of authorisation | |
| 7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation | Confidential |
| 8: Authorisation Date | 09/08/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
PHARMAPAC (UK) LIMITED, UNITS 20 TO 24 AND 29 AND 30, VALLEY ROAD BUSINESS PARK, BIRKENHEAD, CH41 7EL, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.8 ] Other solid dosage forms |
| [ 1.2.2 ] Batch certification |
| [ 1.4 ] Other products or manufacturing activity |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.1 ] Herbal products |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.3 ] Chewing gums |
| [ 1.5.1.5 ] Liquids for external use |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.1.12 ] Suppositories |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.17 ] Other non-sterile medicinal products Assembly of medical devices, THR blended powder for filling into sachets. Homeopathic powder for filling into sachets |
| [ 1.5.2 ] Secondary packaging |
Any restrictions or clarifying remarks
Ointment manufacturing is included to cover cGMP requirements for the Canadian Authority for one product which is classified as a medicinal product in Canada and not a medical device.