Drugs

Department for Business, Energy and Industrial Strategy written question – answered on 28th November 2018.

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Photo of Helen Goodman Helen Goodman Shadow Minister (Foreign and Commonwealth Affairs)

To ask the Secretary of State for Business, Energy and Industrial Strategy, what his assessment is of the potential costs to the pharmaceutical industry of Article 45 of the Draft Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community.

Photo of Kelly Tolhurst Kelly Tolhurst Parliamentary Under-Secretary (Department for Business, Energy and Industrial Strategy)

There will be no cost to the pharmaceutical industry as a result of Article 45 of the draft Withdrawal Agreement. The Article requires the UK to share marketing authorisation data with the European Medicines Agency or Member States where needed for assessing generic marketing applications when requested. Member States will also be required to provide the UK with the same information when requested. The UK’s Medicines and Healthcare Products Regulatory Agency already regularly shares and receives such data with the European Medicines Agency and other Member States.

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