This page provides links to the latest information about the regulation of medicines ('Medicines regulatory news'), current MHRA conferences and consultations relevant to industry, the latest MHRA performance figures and the Better Regulation of Medicines Initiative (BROMI).
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Current consultations |
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Latest news
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06 Feb 2012 | Public consultation (ARM 81): Request to reclassify Imodium Instants (loperamide hydrochloride) 12 tablet pack size from Pharmacy (P) to General Sales List (GSL)
Consultation ARM 81 seeks your views on the reclassification of Imodium Instants (loperamide hydrochloride) 12 tablet pack size from Pharmacy (P) to General Sales List (GSL). Comments are invited by 5 March 2012.
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31 Jan 2012 | Pre-consultation questionnaire for the 'Falsified Medicines Directive' (Directive 2011/62/EU) - closes 3 February 2012
The MHRA is seeking information from industry professionals to inform an initial economic Impact Assessment following publication by the European Commission of Directive 2011/62/EU concerning falsified medicines.
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20 Jan 2012 | MHRA technical validation of marketing authorisation applications (MAAs) for medicines - Updated 20 January 2012
From 3 January 2012, the MHRA will be technically validating all new eCTD (common technical document) submissions.
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12 Jan 2012 | Public consultation (ARM 80): Request to reclassify Clarityn Allergy 10 mg Tablets (Loratadine) 30 tablet pack size from Pharmacy (P) to General Sales List (GSL)
Consultation ARM 80 seeks your views on the reclassification of Clarityn Allergy 10 mg Tablets (Loratadine) 30 tablet pack size from Pharmacy (P) to General Sales List (GSL). The deadline for comments is 8 February 2012.
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11 Jan 2012 | Public consultation (MLX375): Consolidation and review of UK medicines legislation. Reminder - closes 17 January 2012
Consultation MLX 375 seeks your views on the draft consolidated medicines regulations. Reminder - closes 17 January 2012.
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21 Dec 2011 | Consultation MLX 363 - Fees legislation for 2012
This consultation seeks views on proposals to change the levels of fees charged by the MHRA for the regulation of medicines, including herbal and homoeopathic medicines, and blood establishments and blood banks. The deadline for responses is 31 January 2012.
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12 Dec 2011 | Final reminder to cancel medicines licences by the end of December 2011
Holders of authorisations, registrations and licences are required to notify the MHRA by 31 December 2011 to cancel authorisations, registrations and licences from 31 March 2012. If you have not cancelled them yet please do so as soon as possible.
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06 Dec 2011 | Consultation seeks views on the draft regulations transposing the EU Directive 2010/84/EU on Pharmacovigilance
A consultation has been launched seeking views on the draft regulations transposing the EU Directive 2010/84/EU on Pharmacovigilance. This Directive must be transposed to UK law by 21 July 2012. This is accompanied by EU Regulation 1235/2010/EU on Pharmacovigilance, to be transposed by 2 July 2012.
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04 Nov 2011 | MHRA stop sending ASPRs/ICSRs from literature articles to industry
Anonymised Single Patient Reports (ASPRs) and electronic equivalent, E2B Individual Case Safety Reports (ICSRs) sent to industry by the MHRA from ADRs reported in literature articles have been identified by the BROMI Vigilance workstream as an area where significant efficiencies could be made.
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01 Nov 2011 | Good Clinical Practice (GCP) forum launched
A new Agency discussion forum for Good Clinical Practice (GCP) has been launched.
