The European Medicines Agency ("EMA") has published its Guide on access to unpublished documents (the "Guide"). In accordance with European Union ("EU") law, any person may request access to unpublished documents held by the EMA. The Guide is intended to provide practical guidance concerning the process for requesting access to these documents. The new Guide is in the form of a Questions and Answers document and includes a flow chart of the access-to-documents process. The Guide confirms that anyone may request access to any type of document held by the EMA by using the web form (available here). The Guide requests that applicants clearly identify the document to which they would like access. Where applicants do not know the specific document they require, they should provide as much information as possible. An access-to-documents coordinator will then contact the applicant to clarify the request. The Guide explains that once a request has been submitted, the request will be evaluated by the EMA. The EMA will provide its decision concerning whether to grant or refuse access to the document within 15 working days. However, this deadline may be extended to a total of 30 working days. The EMA may refuse access to a document where disclosure would undermine the protection of:

  • public interest as regards public security, defence and military matters, international relations, the financial, monetary or economic policy of the European Union or a Member State;
  • the privacy and integrity of the individual, in particular in accordance with EU legislation regarding the protection of personal data;
  • the commercial interests of a natural or legal person, including intellectual property, unless there is an overriding public interest in disclosure;
  • the purpose of inspections, investigations and audits, unless there is an overriding public interest in disclosure;
  • court proceedings and legal advice, unless there is an overriding public interest in disclosure.
Where a document request concerns a document produced by a third party, the EMA will liaise with that third party to discuss the potential protection of any commercially confidential information and protected personal data, prior to disclosing the document. Where the EMA decides to grant access, the document will be sent to the applicant via a secure system called EudraLink.

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