Important to Exporters of APIs to EU - the new directive of EU
All the Members of Council,
Dear Sir / Madam,
Sub: “Interactive Meeting with European Commission” on 13th September 2012 at 6:00 pm at Hotel Taj Deccan, Hyderabad.
As members are aware about the recent developments in the European Union’s Directive on “New Rules on Importing Active Pharmaceutical Ingredients into the EU”. The European Union (EU) has reformed the rules for importing into the EU active substances for medicinal products for human use.
This new Directive is coming into effect from 2nd July 2013, stating that all imported active substances should be manufactured in compliance with standards of good manufacturing practices (GMP) at least equivalent to the GMP of the EU. The manufacturing standards in the EU for active substances are those of the ‘International Conference for Harmonization’ – ICH Q7.
Council in this context is organizing an “Interactive Meeting with European Commission” on 13th September 2012 at 6:00 pm, followed by Dinner at Hotel Taj Deccan, Hyderabad.
Mr. Stefan Fuehring, Policy Officer, looking after quality, safety and efficacy of medicinal products in the Directorate General of Health and Consumers, European Commission is visiting Hyderabad and will be making presentation/interacting on,
· Quality of Medicines and Technology Solutions on Falsified Medicines
· New rules on importing APIs into the European Union
In view of the above, we request all our member companies to utilize the presence of Mr. Stefan and have the required clarifications for exporting APIs to EU. To defray the expenses, we are charging a nominal fee of Rs.500 towards Registration Fee, payable in the name of Pharmaceuticals Export Promotion Council of India, Hyderabad/Mumbai.
Members interested in attending the Interactive Meeting are requested to confirm their participation by email at
or by fax at 040-23735464.