Find PILs and SPCs for different medicines

Once registered you will receive credentials to access the portal to your registered email address. If you are making a submission using the portal, you will have to submit using the portal forms as well as submitting the eAF. You can also group changes that would have been a notification on their own with changes that need to be submitted for full assessment. All information on packaging for licensed medicines must be printed directly on to the packaging. Use the centralised procedure to get a single licence that can be used to market a product in all EU member states as well as Iceland, Liechtenstein and Norway. Types of application (legal basis) You must include the appropriate legal basis for your application when you apply to mhra for a marketing authorisation: full application - Article 8(3) generic, hybrid or similar biological applications - Article 10 well-established use. Mhra, the Department of Health and the Devolved Administrations will continue to work with the European Commission and other member states on implementation plans for the new regulation. If you have any questions about submitting your application you should email. Decentralised procedure (DCP you should use the decentralised procedure if you want to market the medicine in the UK and other named EU countries. Well send you a link to a feedback form. If you think your submission has been wrongly rejected you should email. Submissions which affect the product information include renewal, variation type II, variation type IB, variation type IA, national 61(3) applications and bromi 61(3) notifications. For more information about fast tracking your marketing authorisation email or call.

Apply for a licence to market a medicine in the

Also see mhra guidance document always read the leaflet - getting the best information with every medicine (PDF, 588KB, 173 pages). European Medicines Agency (EMA). Mutual recognition procedure (including repeat use). An implementation plan has been agreed and published for centrally authorised medicines on the website of the European Medicines Agency. Please view mhra clinical trials guidelines here. Ways to make your submission You can now submit your application via the Central European System Platform (cesp). The notification scheme is based on your declaration that the packaging meets legislative requirements and supporting documentation has been submitted. The complainant and the MA holder both receive a copy of the outcome report, which details the complaint and any action taken. Include your proof of payment as a labelled PDF in the workingdocuments folder of your electronic Common Technical Document (eCTD). To start your application with mhra as the RMS, email with the name of your product and the PL number.

Mhra (2008) Medicines and medical devices

The procedure takes up to 210 days, excluding time taken to provide further information or data required. If the application is approved, mhra and each CMS will issue a national licence for the product within 30 days of the approval being granted. The asmf holder will need to register with the Common European Submission Platform (cesp) and then make their application through cesp. European regulation The regulations for labelling and patient information leaflets are set out in Title V of Council Directive 2001/83/EC which was amended by Council Directive 2004/27/EC and Council Directive 2010/84/EU. Safety features legislation, the European Parliament and Council has approved and published a Delegated Regulation (EU2016/161) in the Official Journal of the European Union. Use the mutual recognition procedure when your product already has a national licence in at least 1 EU country, and you want to market it in more EU countries. You need to use the: You will usually need to submit a paediatric investigation plan (PIP) early in the development of your product. Heads of Medicines Agencies website. Skip to main content, close, help us improve, to help us improve, wed like to know more about your visit today.

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