Industry News - Tag: MHRA

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Regulatory in brief | Allopurinol, PRAC, MHRA

8 September 2021

New Zealand's Medicines Classification Committee (MCC) is set to reconsider an application to change the status of allopurinol for preventing gout, Europe’s Pharmacovigilance Risk Assessment Committee (PRAC) has extended the mandate of its vice chair for a further three years, and the UK’s Medicines...

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Reckitt’s Nuromol gains GSL status in the UK
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19 August 2021

Reckitt’s Nuromol has become the first combination medicine containing ibuprofen and paracetamol to be allowed on general sale outside pharmacies in the UK. The company has been awarded one year of data exclusivity for studies carried out to support the switch from pharmacy (P) to general-sale list...

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UK gives go-ahead to OTC contraceptive pills

9 July 2021

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has given the go-ahead for two oral contraceptive pills – HRA Pharma’s Hana and Maxwellia’s Lovima – to be sold without a prescription. Michelle Riddalls – chief executive officer of the Proprietary Association of Great Britain (PAG...

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Oral contraceptive pill could soon be OTC in the UK
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15 February 2021

Two applications to switch oral contraceptives from prescription-only to pharmacy (POM to P) status in the UK are now out for consultation. If they are approved, then Maxwellia’s Lovima and HRA Pharma’s Hana will become the country’s first OTC oral contraceptive pills.

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Regulatory in brief / CBD, Norway, COVID-19

23 December 2020

The US Food and Drug Administration (FDA) has issued a number of warning letters to cannabidiol (CBD) companies, the Norwegian Medicines Agency (NoMA) is expanding the list of general-sale medicines, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued an exceptional us...

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Regulatory in brief | opioids, pholcodine, Arthrem

23 September 2020

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has introduced stronger warnings for prescribed and OTC medicines containing opioids, while New Zealand’s Medsafe is to reconsider a recent recommendation for pholcodine and has reached a settlement over Arthrem.

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