Stephen O'Brien (Shadow Minister, Health; Eddisbury, Conservative)
To ask the Secretary of State for Health how the Medicine and Healthcare products Regulatory Agency ensures that the procedures that the research and development based pharmaceutical industry has to follow to ensure quality and patient safety is followed by parallel import traders.
Andy Burnham (Minister of State (Delivery and Quality), Department of Health; Leigh, Labour)
The United Kingdom (UK) parallel import licensing scheme, as required by the European treaty, allows medicinal products already authorised in other European Union (EU) member states to be marketed in the UK provided the imported products have no therapeutic difference from the equivalent UK products and do not appear in the light of scientific knowledge to differ as regards their safety and efficacy.
The Medicines and Healthcare products Regulatory Agency (MHRA) liaises closely with the relevant competent authorities in the EU to obtain the necessary information to ensure that only those products which fully comply with the stringent criteria for parallel import are granted a licence.
Quality and patient safety are further ensured by a thorough assessment of the proposed labelling and/or packaging and the patient information leaflet by assessors prior to the issuing of a licence. Repackaging of the imported product when it occurs is carried out by an approved company in possession of a manufacturer's or assembler's licence, issued by the MHRA. In addition, patient information leaflets and/or packaging are kept up to date by variations to the parallel import licences when relevant information becomes available via the MHRA's pharmacovigilance activities.
Parallel import traders are also subject to routine inspections by staff of the MHRA's inspection and standards division.