The guidance and legislation section contains reference to guidance previously published by the MHRA and relevant legislation. The MHRA is not responsible for the content of external internet sites.
Revised EU Guidelines for GDP
Following publication of the revised Guidelines for GDP by the European Commission, the following explanatory note has been prepared in order to clarify the interpretation of the guideline by MHRA. The document is not intended to provide an in depth explanation of the published guideline, and should be read in conjunction with the guide, in order to clarify the expectations of the MHRA Inspectorate for those areas that may be open to individual Member State interpretation.
Responsible Person (RP)
Regulation 45 of the Human Medicines Regulations 2012 state the requirement for a Responsible Person (RP) within the UK.
The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices. The duties of a RP include:
- to ensure that the provisions of the licence are observed
- to ensure that the operations do not compromise the quality of medicines
- to ensure that an adequate quality system is established and maintained
- to oversee audit of the quality system and to carry out independent audits
- to ensure that adequate records are maintained
- to ensure that all personnel are trained
- to ensure full and prompt cooperation with product licence holders in the event of recalls.
In order to carry out his duties, the RP should have a clear reporting line to the licence holder or MD. The RP should have personal knowledge of the products traded under the licence and the conditions necessary for their safe storage and distribution. The RP should have access to all areas, sites, stores and records which relate to the licensable activities and regularly review and monitor all such areas, etc. and the standards achieved.
Further information on the appointment and duties of the RP is available below:
Responsible Person - Gold Standard role profile (external link)
Updated returns policyFollowing publication of the revised Guidelines for GDP by the European Commission, the GMDP Inspectorate have issued an updated returns policy for GDP, which covers both ambient and refrigerated returns.
Guidance on preventing breaches in the cold chain for medicinal products
The attached article provides guidance on the distribution and storage of refrigerated medicines, and is taken from an article originally written for and published in The Pharmaceutical Journal Volume 281 dated 18 October 2008.
The MHRA's Enforcement Group are responsible for the UK anti-counterfeiting strategy. The strategy describes the MHRA approach to combating the availability of counterfeit medicines and devices in the UK. Further information relating to counterfeit medicines and the anti-counterfeiting strategy is available in the Counterfeit medicines and devices section.
Medicines distribution in the maritime sector
The MHRA has recently reviewed guidance on the supply of human medicine to the maritime sector, as a result of this review new guidance has been issued.
The updated guidance, which can be found in the document below, sets out the MHRA expectations for the supply of human medicine to the maritime sector and also gives specific instructions regarding the packing of First Aid Kits.
Short-term storage of ambient and refrigerated medicinal products and the requirement for a wholesale dealers authorisation (WDA)
The document below provides guidance on the short-term storage of ambient and refrigerated medicinal products, to confirm the situations when a wholesale dealers authorisation (WDA) is required.