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PV Audit Strategy and Risk Assessment

PV Audit Strategy and Risk Assessment

From our experience, companies are falling short of their pharmacovigilance obligations with regards to strategic, tactical and operational level PV audit planning. This can lead to areas of non-compliance, risks to patient safety and inspection findings. Outlined...

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BioPharmaChem Impact 24 Conference

BioPharmaChem Impact 24 Conference

We were delighted to attend the 1st ever BioPharmaChem Impact 24 Conference which took place yesterday May 23rd in the beautiful surroundings of Fota Island Resort, Cork.

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Why its better to trust Acorn Regulatory to manage your entire product lifecycle?

Why its better to trust Acorn Regulatory to manage your entire product lifecycle?

Discover the challenges and advantages of outsourcing various pharmaceutical services to multiple providers versus a single service provider. From managing the product lifecycle to ensuring regulatory compliance and communication between teams, find out how a cohesive approach can streamline processes and reduce costs. At Acorn Regulatory, we prioritise your product’s success with our global expertise and commitment to excellence.

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EMA Addresses Stakeholder Queries

EMA Addresses Stakeholder Queries

The EMA has issued Questions and Answers to Stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use.

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MHRA Updated NIMAR Guidance to reflect Windsor Framework

MHRA Updated NIMAR Guidance to reflect Windsor Framework

Get up-to-date information about the Northern Ireland MHRA Authorised Route (NIMAR). Check out the recent MHRA Windsor Framework-aligned guidance changes to ensure the legal supply of POMs in the UK and EU. Discover how the Windsor framework will allow ‘PL GB’ packs to be sold in Northern Ireland in January 2025.

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Labelling and packaging of human-use drugs after Windsor Framework agreement

Labelling and packaging of human-use drugs after Windsor Framework agreement

“MHRA updates guidance for UK medicinal product labeling and packaging. Effective January 1, 2025:EU/UK joint packs not allowed in the supply chain.Medicines in the UK (including Northern Ireland) to be authorized separately by MHRA.EU Falsified Medicines Directive no longer applies; ‘UK only’ labeling required.MAHs must submit ‘UK only’ statement by December 31, 2024, with a 6-month over-sticker transition until June 30, 2025. Brought to you by Acorn Regulatory.”

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Choosing an RMS

Choosing an RMS

Choosing the right Reference Member State (RMS) for your EU procedure can be difficult, Here is some advice to consider, helping you make the choice for your company.

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Marketing Authorisation Holder Responsibilities

Marketing Authorisation Holder Responsibilities

Acorn Regulatory has worked with a number of MAHs including ‘virtual MAH’s’ to help them understand their responsibilities and develop a QMS suitable for their needs and to support them with each of these responsibilities. MA Holding entities are subject to Market Compliance Inspections by any Health Authority, in any EU country where they hold an MA. The HPRA carry out multiple MAH Market compliance inspections each year.

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PRRC: Person Responsible for Regulatory Compliance

PRRC: Person Responsible for Regulatory Compliance

This revised article concentrates on the role of the Person Responsible for Regulatory Compliance (PRRC). The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European Medical Devices legislation that a person is...

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Most Read Explainer Articles of 2020

Most Read Explainer Articles of 2020

Acorn Regulatory’s website has a wealth of articles that assist regulatory, pharmacovigilance and clinical professionals all over the world.  We consistently feature ‘how-to’ and explainer articles.  These are the most read ‘how-to’s’ and explainer articles on our website in 2020.

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