Regulation Updates

Update to the revised guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use

The revised EU GDP Guidelines published in the Official Journal of the European Union by the EU Commission on the 7 March 2013 (2013/C 68/01) and which replaced the GDP Guidelines published in 1994 (94/C 63/03) have been updated. The updated version (2013/C 343/01) of the revised EU GDP Guidelines will be applicable to wholesale distributors of medicinal products for human use from the first day following their publication in the Official Journal of the European Union and, as such, became applicable as of 24 November 2013.

2013/C 343/01 corrects factual mistakes identified in subchapters 5.5 and 6.3 of the revised guidelines (2013/C 68/01). It also gives more explanations on the rationale for the revision as well as a date of coming into operation. It replaces the guidelines on GDP published in March 2013 (2013/C 68/01).

The guidelines will apply not only to wholesalers and manufacturers of medicinal products; it also incorporates specific requirements for brokers involved in activities relating to the sale or purchase of medicinal products.

Other key changes from the 1994 guidelines include requirements relating to Quality Risk Management, Computerised Systems, Qualification and Validation, Management of Outsourced Activities and Transportation. A requirement for contracted storage premises to be covered by a separate wholesale distribution authorisation is clearly stated and there will be further communication from IMB with individual operators in this regard.

Source: Irish Medicines Board / Date: 8-4-14