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Focus on Regulation

Tag Archives: MHRA

The MHRA issues new guidance concerning Own Brand Labelling or “Virtual Manufacturing”

On 29 March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new guidance (hereafter “Guidance“) concerning the Own Brand Labelling of medical devices in the United Kingdom. The Guidance, which is expected to have substantial consequences for the current arrangements between Own Brand Labellers (OBL) and “Original Equipment Manufacturers” (OEM), is

UK to Seek Close Relationship with EMA Post-Brexit

UK Secretary of State for Health, Jeremy Hunt, has stated in a Health Select Committee meeting that he does not expect the UK to remain part of the European Medicines Agency (“EMA”) or the EU medicines regulatory framework post-Brexit, but that the UK should seek a very close working relationship with the EMA and the

UK MHRA to develop quality standards for biological medicines

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines. Public quality standards form part of the regulatory framework governing the quality of all medicines. Both documentary and physical standards exist to ensure that medicines are of acceptable quality for use by

UK MHRA publishes “top tips” for manufacturing authorisation applicants

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on common mistakes made by applicants, to help reduce delays in processing applications. The MHRA is required to grant or refuse applications for manufacturing authorisations within 90 days of receiving a completed application. The

MHRA Publishes Draft Guidance on GxP Data Integrity

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published for public consultation a draft guidance on GxP Data Integrity which includes definitions of key terms. The draft Guidance applies to both paper and electronic data in all areas of GxP (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and

New UK Registration Requirements for Online Medicine Retailers

From 1 July 2015, any UK-based online retailer that sells medicines to consumers in the UK or any EU or European Economic Area (EEA) country must be registered with the UK competent authority, the Medicines and Healthcare Products Regulatory Agency (MHRA). They must also display the EU common logo for online retailers and pharmacies, together

MHRA ANNOUNCES EARLY ACCESS TO MEDICINES SCHEME

On 7 April 2014, the United Kingdom (hereafter “UK”) Medicines and Healthcare Products Regulatory Agency (hereafter “MHRA”) launched the Early Access to Medicines Scheme (hereafter “EAMS”) to provide patients with access to medicinal products that do not yet have a marketing authorisation in the UK. The EAMS is a voluntary scheme which runs in parallel

New Borderline Guide concerning medical devices issued by the MHRA

On 5 February 2014, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published a guidance document[1] intended to assist manufacturers in determining whether their product falls within the definition of a medical device laid down in the Council Directive 93/42/EEC concerning medical devices. In its guidance, the MHRA underlines that a product will be