The European Medicines Agency (EMA) has released guidance today to support marketing-authorisation holders updating the information on authorised medicines that they have submitted to the Agency in accordance with Article 57(2) of the 2010 pharmacovigilance legislation. As of 16 June 2014 and by the end of December 2014, marketing-authorisation holders will be required to update information on their authorised medicines. This will include completing previously submitted information with additional data elements that are included in the new data submission format, bringing medicines information up to date and checking the quality of the information in line with the updated reporting requirements.
The guidance released today includes updates to the legal notice, detailed-guidance documents and controlled vocabularies. The Agency urges marketing-authorisation holders to familiarise themselves with these updated requirements, and make the necessary changes to their data-submission tools before they begin to update and complete the information on their medicines in June.
The Agency has been working closely with representatives of European pharmaceutical-industry associations on the development of these measures through the Joint Implementation Working Group (IWG). The group has endorsed all aspects related to the planning and guidance on maintenance submission process. As previously communicated, marketing-authorisation holders should continue to notify the EMA of any new marketing authorisations within 15 calendar days from the date of notification of the granting of the marketing authorisation by the competent authority.
From January 2015 at the latest, marketing-authorisation holders will be required to continue maintaining the information on medicines by:
- notifying the Agency of any new marketing authorisations within 15 calendar days from the date of notification of the granting of the marketing authorisation by the competent authority;
- notifying the Agency of any amendments to the term of marketing authorisation by means of the same business processes and within 30 calendar days from the date of which the changes have been authorised.
Marketing-authorisation holders will need to follow these transition maintenance submission processes until the implementation of the International Standards on Identification of Medicinal Product (i.e. ISO IDMP standards) in 2016.
The Agency is cooperating with the European Union (EU) regulatory network and European pharmaceutical-industry associations on the development of a roadmap towards the implementation of the ISO IDMP standards, taking into account the progress on international harmonisation activities. The Agency, in liaison with pharmaceutical-industry associations, is currently developing guidance to outline the data quality-control methodology and principles that marketing-authorisation holders will need to apply. This guidance will clarify the scope and intended use of the information submitted under Article 57 requirements with the aim of improving the quality of the data submitted by marketing-authorisation holders. The Agency plans to release this guidance in March 2014.
Further information can be found on the Agency’s webpages on data submission requirements, which have been revised to provide clearer guidance to industry on their obligations and on the Agency’s processes.
In line with Article 57(2) of the 2010 pharmacovigilance legislation, all holders of marketing authorisations for medicines in the European Union (EU) must submit information to the European Medicines Agency on all medicines authorised for use in the EU and keep this information up-to-date. This is a legally binding requirement from the EU pharmaceutical legislation. The information is being used to support pharmacovigilance data analysis, to facilitate medicines regulation and fulfil regulatory actions and legal obligations, and strengthen communication with the Agency’s stakeholders and partners.
Marketing-authorisation holders were initially required to submit information on all human medicines authorised in the EU by 2 July 2012. Since July 2012, marketing-authorisation holders have had to submit information on new marketing authorisations granted after 2 July 2012.