The European Medicines Agency (“EMA”) has updated its guidance documents to reflect new European Union (“EU”) requirements which require Marketing Authorisations Holders (“MAHs”) to update the information they submitted to the EMA on authorised medicinal products in the EU.
Under the new EU pharmacovigilance rules, MAHs are, since July 2012, required to electronically submit information on all new market authorisations for medicinal products.
From 1 July 2016, the EMA will be required to implement the International Organization for Standardization (“ISO”) Identification of Medicinal Products (“IDMP”) standards for the submission of information on medicinal products. In order to prepare for the application of the IDMP standards, the EMA has entered a transition phrase during which all the information submitted on authorised medicinal products shall be up-to-date, complete and of high quality by the end of 2014.
Requirements under the updated guidance
On 31 January 2014, the EMA published updated guidance documents intended to ensure that MAHs submit revised information on authorised medicinal products to update the information that they have submitted to the EMA since July 2012, and to bring the information in line with the updated guidance and quality standards. These updated guidance documents consist of a Legal Notice concerning the information on authorised medicinal products which must be submitted to the EMA and two Detailed Guidance documents on the electronic submission of the information (Guidance 1, Guidance 2).
From 16 June 2014, MAHs must ensure that the information on medicinal products that they have submitted to the EMA is in line with the updated guidance. This may involve the completion of the information previously submitted from July 2012, updating information and checking the quality of the information in line with the updated requirements published by the EMA. MAHs have until the end of 2014 to complete this process.
Furthermore, MAHs are required to continue to submit information on any new marketing authorisations granted after 2 July 2012 within 15 calendar days from the date of notification of the granting of the marketing authorisation by the EMA or the national competent authority. This information should also be complete before the end of 2014.
MAHs must ensure that all the information on authorised medicinal products submitted to the EMA corresponds with the information requirements outlined in the Legal Notice. This required information includes:
- A description of the medicinal product;
- A description of the pharmacodynamic properties of the medicinal product;
- Details of the marketing authorisation holder;
- Details of the marketing authorisation and its status;
- A description of the medicinal product type;
- A description of the therapeutic indications;
- Details of the qualitative and quantitative composition of the medicinal product; and
- An electronic copy of the latest approved Summary of Product Characteristics (“SmPC”) including version date, document reference number(s) and document language(s).
Furthermore, MAHs are required to notify the EMA of any amendments to the marketing authorisation of the medicinal product, which includes the following information:
- Extensions of the marketing authorisation;
- Variations to the marketing authorisation;
- Amendments to the pharmacovigilance contact information;
- Transfers of marketing authorisations;
- Suspension/lifting of the suspension, revocation or withdrawal of a marketing authorisation granted in the EU;
- Renewal of the marketing authorisation;
- Variations that lead to a significant revision to the SmPC by submitting the electronic copy of the latest approved SmPC.
Following completion of this process, which should occur by the end of 2014, MAHs will have a maintenance obligation to keep the information up-to-date and in line with any all regulatory requirements. Additionally, MAHs must notify the EMA of any amendments to the marketing authorisation following variation, transfer, renewal, suspension, revocation or withdrawal no later than 30 calendar days from the date of which the amendments have been authorised.
The EMA may review the quality and integrity of the information submitted, and, if necessary, request the MAH to update the information accordingly. To assist MAHs in complying with the data quality requirements, the EMA will publish a guidance document. The guidance document is expected to be available in March 2014.
Electronic submission of information
From 16 June 2014, MAHs will be required to apply the updated technical specifications on eXtended EudraVigilance Medicinal Product Report Message (“XEVPRM”) schema as the format to electronically submit information on all medicinal products in the EU to the EMA. The EMA has published a guidance document for users on the application of the new XEVPRM technical specifications.