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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

10 09, 2019

EU: First steps taken to diminish drug shortages

By |2019-09-10T09:55:50+00:00September 10th, 2019|Uncategorized|

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

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

15 08, 2019

What is considered GMP-compliant equipment design?

By |2019-08-15T10:11:08+00:00August 15th, 2019|General News|

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

1 08, 2019

Brexit: Industry should keep Timelines for Batch Testing Facilities

By |2019-08-01T16:13:35+00:00August 1st, 2019|Uncategorized|

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.

31 07, 2019

The meaning of Market Access

By |2019-07-31T09:59:19+00:00July 31st, 2019|Uncategorized|

Market Access is the process to ensure that all appropriate patients who would benefit, get rapid and maintained access to the brand at the right price. Understanding the process: It is important to understand all the processes that impact market access, both internal and external: Payers have processes – at national level

19 07, 2019

GMP Requirements in the European Union

By |2019-07-19T12:43:01+00:00July 19th, 2019|Technical Article|

GMP Requirements in the EU: The contents of this article will discuss GxP, Good Manufacturing Practice, Good Distribution Practice and Market Authorisation Holder compliance overview. EU requirements differ from those anywhere else in the world. To import a product into the EU you must abide by European GMP requirements. There is

17 07, 2019

A milestone has been reached by the EU and US (MRA)

By |2019-07-17T11:28:47+00:00July 17th, 2019|Uncategorized|

With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories. Each year, EU national authorities and the FDA inspect many

11 07, 2019

Canada’s Cannabis Products: New Regulatory Approach

By |2019-07-11T11:10:55+00:00July 11th, 2019|General News|

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

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