The wholesale distribution of medicinal products and active substances is an important activity. The quality and the integrity of medicinal products can be affected by a lack of adequate control. The quality, safety and efficacy of medicinal products depend on a whole range of different factors. The most important factors are that
Last week, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) released their “Safe Importation Action Plan”. The action plan would allow importation of certain prescription drugs from Canada and other countries. Importing drugs, whether from Canada or elsewhere in the world, poses a big
Last week, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) released their “Safe Importation Action Plan”. The action plan would allow importation of certain prescription drugs from Canada and other countries. Importing drugs, whether from Canada or elsewhere in the world, poses a big
A question that gets frequently asked is what GMP-compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products / APIs. The short answer is: the system must be qualifiable. Since this require some clarification, here
Health Canada has proposed a regulatory pathway for a new class of cannabis products known as Cannabis Health Products (CHPs). On June 19, 2019, Health Canada started a consultation on potential market for CHPs that would not require a practitioner’s oversight. Health Canada are accepting comments until September 3, 2019. There is
Medicinal cannabis is being made available under a pilot programme. The pilot programme which allows access to cannabis-based products for medical use has been launched by the Minister for Health, Simon Harris. Legislation giving the go ahead for the Medical Cannabis Access Programme to operate in Ireland was signed yesterday by Simon
The European Medicines Agency (EMA) announced on Tuesday that Luxembourg and The Netherlands have now joined the mutual recognition agreement for Good Manufacturing Practice (GMP) inspections between the US Food and Drug Administration (FDA) and EU member states. This announcement comes six months after Cyprus and Bulgaria joined the agreement. The MRA,
Now featuring in this month's in-flight Aer Lingus Cara magazine, an interview with our CEO, Ann McGee. The interview titled 'A day in the life' comes following our win at the 'Aer Lingus Start Up Awards 2018'. The interview provides a great insight into the daily routine of Ann and her busy
Following the European Medicines Agency leaving its London premises on 1 March, the agency is now operating from Amsterdam. The staff will gradually move into the Spark building in Amsterdam Sloterdijk. The EMA has been working hard with the Dutch authorities to ensure these temporary premises would be ready to move into
In relation to the decision on whether a deal will be made or not on Brexit, the outcome will have a big threat on pharmaceutical research and manufacturing in the United Kingdom, the industry has said. This will potentially be driving up manufacturing costs and minimising future investment. A range of companies
