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, regulated by Joint Ordinance No. 1/2017.

Turkey -  Pharmaceutical Business After the Coup

As you all knew, at the end of July 2016, Turkey has suffered a failed coup attempt.   After that the government took some serious even excessive measures to clean the putschist or anyone related to these people from the state agencies. Around 80,000 personnel, working at the different agencies of the State were either fired or suspended. At the Ministry of Health, 115 senior director, 1504 physician, total 5581 personnel have been removed from duty.

New European Regulations for mHealth apps

The Draft of Code of Conduct on privacy for mobile health apps has now been formally submitted for comments to the Art 29 Data Protection Working Party. Once approved by this independent EU advisory group, the Code will be applied in practice: App developers will be able to voluntarily commit to follow its rules, which are based on EU data protection legislation. Here is the link to Draft version of Code of Conduct

FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is Out

New Rules for Food Supplement Exporters to USA

The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is now final, and compliance dates for some businesses begin in 18 months, starting with 13th November 2015.

The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. This rule is the product of a significant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal and international regulatory counterparts, academia and other stakeholders. The FDA first proposed this rule in July 2013.

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 pharmacies or retailers of medicines legally operating in the European Union should display a new logo introduced by the Directive 2011/62/EU. Click here to downlaod the Directive. 

Freelancers are Earning More than Full Time Employees? 

The payment gateway company recently surveyed more than 23,000 freelancers and according to the results they nowadays earn more money than the average non-freelance worker, at least in some countries. Sounds like a great development for all independent pharma consultants !

In one of the most comprehensive studies of its kind, they surveyed more than 23,000 freelancers worldwide to determine average billing rates based on factors including experience, gender and skills.