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 [...]
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So far Richie D has created 38 blog entries.
Fighting counterfeit drugs with blockchain technology… The Asia-Pacific pharmaceutical giant Zuellig pharma is using a blockchain platform by SAP to assist consumers identify the medicines place of origin. With 1 in 10 medicinal products that are used in developing countries deemed fake, there is a substantial need to eradicate counterfeit drugs that [...]
The Health Products Regulatory Authority (HPRA) have released a 'Brexit Preparedness' checklist. The checklist has been divided into four parts which include: Supply Chain Customs Medicines Regulatory Compliance Medical Devices Supply Chain In relation to the supply of medicines and medical devices, companies are requested to: Map your supply chain to [...]
Regulators in the European Union (EU) have began taking the first steps reduce shortages of medicinal products. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) recently published two guidance documents. The two guidance documents are said to be used as a foundation. The first guidance document that has [...]
MIAS Pharma are delighted to announce that we have been shortlisted in the Pharma Industry Awards 2019 for the 'Pharma Contract Services of the Year' category. The Pharma Industry Awards were set up to recognise and celebrate the most original and innovative companies which show excellence in the Irish Pharma Sector. There [...]
Further guidance on the regulation of medicines, medical devices and clinical trials if there’s no Brexit dealRichie D2019-08-30T12:13:20+01:00
The Medicines & Healthcare products Regulatory Agency (MHRA) have released further guidance on the regulation of medicines, medical devices and clinical trials if there is no Brexit deal. In relation to medicines: The transitional provision in legislation will ensure that all currently granted Centrally Authorised Products (CAPs) automatically become UK MAs on [...]
With the appointment of Boris Johnson as Prime Minister, it is likely that the United Kingdom (UK) may leave the European Union (EU) on the 31st of October 2019 and without a deal (“Hard Brexit”). Pharmaceutical authorities see challenges for pharmaceutical manufacturers in many areas, not only in terms of drug availability [...]
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 [...]
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 [...]
A reminder was sent out to stakeholders of the European Medicines Agency (EMA) which pointed out that, independent from the extension of the date for the UK’s withdrawal from the EU (Brexit) to the 31st of October 2019, Marketing Authorisation Holders (MAH’s) should use the remaining time to complete all necessary preparations. [...]