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This page includes information on periodic safety update reports (PSURs), European Union (EU) reference dates for medicines and the frequency of submission of PSURs.PSURs are reports providing an evaluation of the benefit-risk balance of a medicine.MAHs must in all cases comply with the requirements of Community legislation.Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.Join us at the USPTO Texas Regional Office where we will be hosting an interactive Q&A session with the Trademark Experts. During this presentation, USPTO representatives will give basic overview of... The permanent PPH program, which started on September 1, 2012,…Washington - The U. Department of Commerce's United States Patent and Trademark Office (USPTO) today announced its call for exhibitors for the 2013 Innovation Expo, to be held on the agency's Alexandria, Va. Free and open to the public, the Expo will feature patented and…The presentation will cover on navigating the USPTO Trademark, Electronic Search System (TESS) and the Identification of Goods and Services Manual. Author U Extravaganza is an annual author and book publishing event including workshops on marketing, sales, editing, digital publishing and many more topics. The Silicon Valley USPTO hosts an interactive question and answer session with the Trademark Assistance Center (TAC) . Patent and Trademark Office (USPTO), in collaboration with other partners located across the region (see available locations below), will host quarterly interactive sessions with experts from the USPTO's Trademark Assistance Center (TAC), which is based at USPTO... Marketing authorisation holders (MAHs) must submit PSURs at defined time points following a medicine’s authorisation.PSURs summarise data on the benefits and risks of a medicine and include the results of all studies carried out with this medicine, both in its authorised uses and in unauthorised uses.

The format of PSURs shall follow the structure described in the Commission implementing Regulation (EU) No 520/2012.

Revised topics are marked 'New' or 'Rev.' upon publication.

A PDF version of the entire post-authorisation guidance is available: These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

The Agency uses the information in PSURs to determine if there are new risks identified for a medicine or whether the balance of benefits and risks of a medicine has changed.

It can then decide if further investigations need to be carried out or can take action to protect the public from the risks identified, such as updating the information provided for healthcare professionals and patients.




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