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Regulatory Affairs

Update about ANVISA´s role in pharmaceutical patent applications

In August 2017, the Brazilian Health Surveillance Agency (ANVISA) published Resolution No. 168/2017, which establishes the administrative procedures related to ANVISA´s “prior consent” for the granting of pharmaceutical patent applications,

By |2020-04-01T12:48:04+01:00March 12th, 2018|Regulatory Affairs|0 Comments

From 1st July 2015 License is Required for On-line Sales of Medicinal Products in EU

If you are an online seller of medicinal products in EU, then you are directly affected by the EU Falsified Medicinal Products Directive 2011/62/EU. From 1st July 2015, all online

By |2020-04-01T12:48:35+01:00July 28th, 2015|Regulatory Affairs|0 Comments

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes,1 cardiovascular disease,2 and infectious disease.3 Within the last two decades, the U.S. Food and Drug

By |2020-04-01T12:48:36+01:00March 3rd, 2014|Regulatory Affairs|0 Comments

Malta as Reference Member State in the Decentralised Procedure

Since 2007 the Medicines Authority is accepting applications as Reference Member State in the Decentralised Procedure. Until further notice, the applications considered will be those for solid oral dosage forms

By |2020-04-01T12:48:36+01:00February 8th, 2012|Regulatory Affairs|0 Comments