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  • Novidades 16 de Outubro de 2019 0




QUESTIONS AND ANSWERS - VERSION 16 - Released 25 September 2019





Brexit: RPs for Import from the EU


Version 16 of the Q&As on Safety Features for Track & Trace

The just published Version 16 of the Q&A´s on Sefety Features puts a strong focus on Q&As addressing false alerts due to incorrect scanning by end-users.


Ph. Eur. 2.4.20. Determination of elemental impurities

A complete revision of Ph. Eur. chapter 2.4.20. Determination of elemental impurities has been published in Pharmeuropa.


How to get GMP Certificates, Importation Licenses & Broker Registrations in UK?

The MHRA recently provided details for new licence applications and variations on the agency´s Inspectorate Blog - together with some helpful links


From Valsartan to Ranitidine: Nitrosamine Impurities and the Measures taken by the EMA and the EDQM

In June 2018, when it became known that the antihypertensive medicinal product Valsartan contained nitrosamines, no one had any idea how widespread these unwanted side-products were. Read more here to find out what action the EMA and EDQM have taken in the past and in response to the latest cases of nitrosamine contamination.





EDQM: transparency and dialogue are key in achieving pharmacopoeial harmonisation

On the occasion of the 30th Anniversary of the Pharmacopoeial Discussion Group (PDG), Susanne Keitel, Director of the EDQM, highlighted the progress achieved by the Group towards pharmacopoeial harmonisation and its key role in reducing the need for redundant testing by manufacturers, hence increasing the availability of medicines.


Delays in treatment of requests for revision and renewal of CEPs

The EDQM is currently having some difficulty in achieving the assessment times for revisions and renewals of CEP applications - both initial requests and assessment of responses to requests for information. The delay is currently around 5 weeks (i.e. the outcome of the assessment is being communicated 5 weeks after the expected date).




European countries increase commitment to responsible antibiotic use in animals

A report published by EMA shows that European countries continue to reduce the use of antibiotics in animals. The overall sales of veterinary antibiotics across Europe dropped by more than 32% between 2011 and 2017. 


European Medicines Agency active-substance-master-file-number request form

Template or form.




FDA approves new treatment for patients with migraine

The U.S. Food and Drug Administration today approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Reyvow is not indicated for the preventive treatment of migraine.





Brexit: RPs for Import from the EU

The scenario of a so called "Hard Brexit" (the United Kingdom - UK - to leave the EU with no deal) is still a possibility. All parties involved started plans for such eventuality, including governments and authorities.


FDA to introduce Wholesale Distributor Verification Requirements

The US Food and Drug Administration FDA has published a Compliance Policy Guidance for Industry "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product".




(No new developments)





UPDATE - 'Blue-box' requirements

(October 2019) - CMDh/258/2012/Rev.17 October 2019



Cover letter template for renewals 

(September 2019)


CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 

(September 2019)


CMDh Q&As on the implementation of the outcome of the Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

(September 2019)


NEW - Timetables 2020 for requests to CMDh for a recommendation on classification of an unforeseen variation - Article 5;


UPDATE - Template - RMS End of Renewal Procedure






Reinstatement of ICH Q3C(R6) Guideline available now on the ICH website

In October 2018, further to a discrepancy raised regarding the Permissible Daily Exposure (PDE) for ethyleneglycol, an error correction procedure was launched and the Q3C(R7) Guideline was released with a new value for the PDE for ethyleneglycol.





Haloperidol, solução injetável - Alteração da via de administração

A informação aprovada para o medicamento Haldol Decanoato, solução injetável, foi objeto de uma harmonização a nível Europeu. Como resultado da avaliação deste procedimento, além das alterações à informação do medicamento, a administração destes medicamentos ficou recomendada apenas por via intramuscular de forma a minimizar o risco dos efeitos cardíacos, nomeadamente do prolongamento do intervalo QT.

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