MHRA (GxP) Inspections during COVID19


The COVID19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. MHRA understands the impact of its work on industry, NHS and patients. This is not just in terms of our regulatory support to bring new technologies and products quickly and safely to market, but also [...]

MHRA (GxP) Inspections during COVID192020-10-12T13:20:44+01:00

Regulations for Pharmaceuticals Post Brexit


The European Commission has published a Communication to prepare for the end of the transition period. The document is appropriately entitled "Getting ready for changes - Communication on readiness at the end of the transition period between the European Union and the United Kingdom". Far-reaching changes and consequences are therefore to be [...]

Regulations for Pharmaceuticals Post Brexit2020-10-12T13:43:15+01:00

Complying with new GDP requirements


In an ever changing and complex industry the role of the Responsible Person has developed and grown over the past 10 years as the focus of regulatory bodies have placed a higher level of scrutiny on how GDP principals are implemented and applied for Wholesale Distributors. Initially the main areas of compliance [...]

Complying with new GDP requirements2020-10-01T14:34:12+01:00

QP Responsibilities


MIAS Pharma provides QP services for commercial and investigational medicinal products. Our QPs have experience in oversight and release of multiple types of products. Each type of product has it's own specific properties and challenges, which determines what approach should be taken to provide the best solutions. Sterile products have to be [...]

QP Responsibilities2020-09-29T16:00:24+01:00

Pharma Industry Awards 2020


We’re pleased to announce that MIAS Pharma Ltd has been shortlisted for Pharma Supplier of the Year in this years Pharma Industry awards. We look forward to a great evening and catching up with our peers and suppliers. Since launching in 2014, the Pharma Industry Awards has established itself as the benchmark for those [...]

Pharma Industry Awards 20202020-09-21T13:08:49+01:00

Good Distribution Practice (GDP): Issue of Theft


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 [...]

Good Distribution Practice (GDP): Issue of Theft2019-09-24T14:56:53+01:00

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


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 [...]

Safety is top concern for recent U.S. drug importation proposal2019-08-19T11:20:19+01:00

What is considered GMP-compliant equipment design?


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 [...]

What is considered GMP-compliant equipment design?2019-08-15T10:11:08+01:00

Canada’s Cannabis Products: New Regulatory Approach


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 [...]

Canada’s Cannabis Products: New Regulatory Approach2019-07-11T11:10:55+01:00

Medicinal cannabis now being made available under a pilot programme


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 [...]

Medicinal cannabis now being made available under a pilot programme2019-06-28T13:55:16+01:00
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