India’s Marketing Regulations of Drugs
Approval of the drug product for import, manufacturing and marketing in India, its demonstration for safety and efficacy in humans is essential. The Rules 122A, 122B and 122D, 122 DA,
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
Banishment of Unlicensed Herbal Remedies in the UK
Thousands of patients in the UK facing the decision about the banning of more than 200 herbal products. For some, this decision is discriminatory and shameful. The same measures are
PIM – Innovative Solution for Ensuring Consistent and High-Quality Product Information
EMA (ex EMEA) is performing a pilot phase of what is known as a Product Information Management system (PIM). It is about interactive IT interface for the submission, review and
Changes in Russian Regulatory Environment
Russia, as one of largest and most important pharmaceutical markets in the world underwent significant changes of its pharmaceutical regulatory laws. The new law went into effect in September 2010.
Confession of GMP-certificates in Ukraine
The Ministry of Health of Ukraine issued an order #896 concerning the renewed GMP-certificate by vendors for selling drugs on the territory of Ukraine. "Good manufacturing practice" or "GMP" is
Understanding USP 71 Sterility Tests and Extended BUD
One of the most frequently asked questions recently asks how to extend the Beyond-Use Date (BUD) of compounded sterile preparations (CSPs). Eric S. Kastango, RPh, MBA, FASHP, reviewed the requirements
Ukraine in Prospect of Joining PIC/S
19-20 May 2010 in Geneva a meeting of the Executive Committee of the PIC / S was held. The Ukrainian delegation, headed by Alexei Soloviev, Chairman of the State Inspectorate
Croatia – Agreement on Ethical Advertising of Reimbursed Drugs
Due to the new Croatian Ordinance on pricing and reimbursement from this year , every MAH who wants to have its products on reimbursement list in Croatia has to sign
International Conference on Counterfeit Medical Products
Basel (Switzerland), 16.04.2010 - More than 140 participants, senior officials from health, law enforcement and judicial authorities from around 40 states, international organisations and institutions from around the world came together on