Q2 2018 Regulatory Update Regulatory Update June 2018 Europe Detail EMA Annex 16 Supplementary Requirements Active substance inspections EMA participates in a programme to rationalise GMP inspections of active substance manufacturers at international level. The aim is to foster cooperation and mutual confidence International collaboration on between participating regulators through better communication GMP API inspections and exchange of information on inspections. The programme facilitates sharing of information on inspection planning and outcomes, and organisation of joint inspections for manufacturing sites of common interest. Please click EMA preparations for Brexit, Key achievements in 2017, Fostering innovation and access to medicines as well as the core statistics from 2017 that highlight the main outcomes of the EMA 2017 annual report and point to interesting trends and changes Agency’s activities observed in recent years. Please click Summary record - technical The European Commission DG SANTE convened a technical expert seminar on expert seminar on pharmaceuticals related matters in order to pharmaceuticals related discuss matters related to preparedness of the UK withdrawal. matters, following UK withdrawal Minutes from the meeting are Publication of updated Q+As and practical guidance Guidance for pharmaceutical The European Medicines Agency (EMA) and the European companies to prepare for Commission have updated their guidance to help UK’s withdrawal from EU pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). Please click The European Commission has proposed to introduce an manufacturing to Supplementary Protection ‘export waiver’ Export manufacturing waiver to Certificates (SPCs) to pharmaceutical companies ‘help Europe’s Supplementary Protection tap into fast-growing global markets and foster jobs, growth and Certificates investments in the EU’. Please click MHRA are seeing a growing use of false NHS and private prescriptions to obtain medicines from Marketing Authorisation Holders (MAH). Prescriptions are requested by the MAH for a Obtaining medicines for variety of reasons, but mainly to provide evidence the product is wholesale using prescriptions / needed for a patient. Typically prescriptions are requested for important update on attempted high cost medicines not usually seen in dispensing pharmacies. thefts from warehouses Redacted prescriptions are presented by a pharmacy to the MAH, implying there is a patient, the product is supplied, but is then wholesaled and not dispensed to a patient. Please click for the MHRA Inspectorate Blog In addition, the following regulations have been developed around the rest of the world:
Q2 2018 Regulatory Update Regulatory Update June 2018 Europe Detail EMA Annex 16 Supplementary Requirements International collaboration on GMP API inspections Active substance inspections EMA participates in a programme to rationalise GMP inspections of active substance manufacturers at international level. The aim is to foster cooperation and mutual confidence between participating regulators through better communication and exchange of information on inspections. The programme facilitates sharing of information on inspection planning and outcomes, and organisation of joint inspections for manufacturing sites of common interest. Please click EMA 2017 annual report EMA preparations for Brexit, Key achievements in 2017, Fostering innovation and access to medicines as well as the core statistics from 2017 that highlight the main outcomes of the Agency’s activities and point to interesting trends and changes observed in recent years. Please click Summary record - technical expert seminar on pharmaceuticals related matters, following UK withdrawal The European Commission DG SANTE convened a technical expert seminar on pharmaceuticals related matters in order to discuss matters related to preparedness of the UK withdrawal. Minutes from the meeting are Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU Publication of updated Q+As and practical guidance The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). Please click Export manufacturing waiver to Supplementary Protection Certificates The European Commission has proposed to introduce an ‘export manufacturing waiver’ to Supplementary Protection Certificates (SPCs) to ‘help Europe’s pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU’. Please click Obtaining medicines for wholesale using prescriptions / important update on attempted thefts from warehouses MHRA are seeing a growing use of false NHS and private prescriptions to obtain medicines from Marketing Authorisation Holders (MAH). Prescriptions are requested by the MAH for a variety of reasons, but mainly to provide evidence the product is needed for a patient. Typically prescriptions are requested for high cost medicines not usually seen in dispensing pharmacies. Redacted prescriptions are presented by a pharmacy to the MAH, implying there is a patient, the product is supplied, but is then wholesaled and not dispensed to a patient. Please click for the MHRA Inspectorate Blog In addition, the following regulations have been developed around the rest of the world: