15 08, 2022

Annex 21 in Effect from August 21st 2022

By |2022-08-22T09:07:54+00:00August 15th, 2022|Featured, Industry News, News|

The new Annex 21, The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, is now in effect. Are you prepared for it's changes? There are a number of key requirements for a Manufacturing Import Authorisation (MIA) holder when

27 07, 2022

Extension of the comment period by FDA

By |2022-10-18T16:03:00+00:00July 27th, 2022|Featured, General News, Industry News|

FDA Proposed Rule "National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers" In February 2022, the FDA has announced the availability of the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)". The proposed rule sets national licensing standards for both federal and

19 09, 2019

Pharma giant tackling counterfeit drugs using blockchain

By |2021-08-01T14:55:41+00:00September 19th, 2019|Industry News|

MIAS PHARMA UPDATEFighting 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 could

17 09, 2019

Brexit Preparedness Checklist – HPRA

By |2019-09-17T11:32:15+00:00September 17th, 2019|Industry News|

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

30 08, 2019

Further guidance on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

By |2019-08-30T12:13:20+00:00August 30th, 2019|Industry News|

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

21 08, 2019

Hard-Brexit: MHRA preparations and impact on clinical trials

By |2021-10-13T14:36:36+00:00August 21st, 2019|Industry News|

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 and

4 07, 2019

Serialisation: New Guidance for EU Inspectors

By |2022-10-25T16:07:59+00:00July 4th, 2019|Industry News|

In 2011, the European Commission (EC) published Directive 2011/62/EC, the Falsified Medicines Directive (FMD). The main objective was to support the fight against counterfeit medicines. The new Directive had a big influence on the pharmaceutical supply chain. It introduced numerous Delegated Acts requiring certain safety features (Unique Identifier and Anti-Tampering Device), had

1 07, 2019

EMA’s quality guideline for drug device combinations

By |2019-07-01T13:47:50+00:00July 1st, 2019|Industry News|

The European Medicines Agency (EMA) have released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation. This guideline provides guidance on the documentation expected for Drug-Device Combinations in the quality part of the dossier

24 05, 2019

EU – FDA MRA has approved two more countries

By |2019-05-24T13:32:15+00:00May 24th, 2019|Industry News|

With the Mutual Recognition Agreement (MRA) between Europe and the USA, inspections are to be mutually recognised in the future. The Food & Drug Association (FDA) approval of EU member states continue to proceed successively. Two more countries have recently been approved, they are Bulgaria and Cyprus. That means there is now

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