24 09, 2019

Good Distribution Practice (GDP): Issue of Theft

By |2019-09-24T14:56:53+00:00September 24th, 2019|General News|

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

19 08, 2019

Safety: Top concern for drug importation proposal

By |2022-10-25T15:56:45+00:00August 19th, 2019|General News|

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

19 08, 2019

Safety is top concern for recent U.S. drug importation proposal

By |2021-10-13T14:36:55+00:00August 19th, 2019|General News|

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

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

11 07, 2019

New Regulatory Approach for Cannabis Products!

By |2022-10-18T15:30:42+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

27 06, 2019

Medicinal cannabis now being made available under a pilot programme

By |2019-06-27T12:07:36+00:00June 27th, 2019|General News|

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

13 06, 2019

The EU-US Mutual Recognition Agreement Adds Luxembourg & Netherlands

By |2019-06-13T13:24:29+00:00June 13th, 2019|General News|

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,

5 04, 2019

Aer Lingus Cara Magazine Interview

By |2019-04-05T13:18:37+00:00April 5th, 2019|General News|

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

13 03, 2019

EMA now operating from Amsterdam

By |2019-03-13T14:33:51+00:00March 13th, 2019|General News|

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

20 02, 2019

Are there Brexit contingency plans for the pharmaceutical industry?

By |2019-02-20T14:24:33+00:00February 20th, 2019|General News|

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

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