Freedom of Information request on the status of ranitidine products in the UK (FOI 22/030)
Published 31 May 2022
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FOI 22/030
31st January 2022
Dear,
Thank you for your email of 4th January 2022 requesting information on the status of ranitidine products in the UK.
The European Medicines Agency (EMA) initiated a review under Article 31 of Directive 2001/83/EC on 12/09/2019, at the request of the European Commission (EC), to evaluate the potential root causes of the reported presence of N-nitrosodimethylamine (NDMA) or other nitrosamines in ranitidine medicines, the possible endogenous formation of NDMA in humans following treatment with ranitidine products, and the impact on the benefit-risk balance of these medicines.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the suspension of all ranitidine medicines in the EU due to the presence NDMA impurities on 17/09/2020; further information about the Article 31 referral procedure is available on the EMA website at: https://www.ema.europa.eu/en/medicines/human/referrals/ranitidine-containing-medicinal-products
The outcome of the referral was adopted by the EC and published in the EC Implementing Decision C(2020) 8429 final of 24/11/2020.
The MHRA, following the outcome of the Article 31 referral (EMEA/H/A-31/1491) and the EC Implementing Decision C(2020) 8429 final https://ec.europa.eu/health/documents/community-register/2020/20201124148388/dec_148388_en.pdf suspended all UK marketing authorisations for ranitidine containing products for human use.
The marketing authorisations will remain suspended until the conditions which are set out in Annex III https://ec.europa.eu/health/documents/community-register/2020/20201124148388/anx_148388_en.pdf of the EC decision are met by the relevant marketing authorisation holders.
Each marketing authorisation holder is required to carry out the necessary investigations and analytical work to fully address the conditions set out in Annex III; the MHRA will reinstate a marketing authorisation once reassured that all the conditions have been met.
All relevant information communicated to marketing authorisation holders about the suspension of marketing authorisations for ranitidine-containing medicines for human use and conditions for reinstatement of the authorisations can be accessed via the above links to the EC Decision and the relevant Annex.
If you have a query about the information provided, please reply to this email.
If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk
Due to the ongoing Covid-19 pandemic, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.
After that, if you remain dissatisfied, you may write to the Information Commissioner at; The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire
SK9 5AF
They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.
Yours sincerely
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000FOI 22/030
31st January 2022
Dear,
Thank you for your email of 4th January 2022 requesting information on the status of ranitidine products in the UK.
The European Medicines Agency (EMA) initiated a review under Article 31 of Directive 2001/83/EC on 12/09/2019, at the request of the European Commission (EC), to evaluate the potential root causes of the reported presence of N-nitrosodimethylamine (NDMA) or other nitrosamines in ranitidine medicines, the possible endogenous formation of NDMA in humans following treatment with ranitidine products, and the impact on the benefit-risk balance of these medicines.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the suspension of all ranitidine medicines in the EU due to the presence NDMA impurities on 17/09/2020; further information about the Article 31 referral procedure is available on the EMA website at: https://www.ema.europa.eu/en/medicines/human/referrals/ranitidine-containing-medicinal-products
The outcome of the referral was adopted by the EC and published in the EC Implementing Decision C(2020) 8429 final of 24/11/2020.
The MHRA, following the outcome of the Article 31 referral (EMEA/H/A-31/1491) and the EC Implementing Decision C(2020) 8429 final https://ec.europa.eu/health/documents/community-register/2020/20201124148388/dec_148388_en.pdf suspended all UK marketing authorisations for ranitidine containing products for human use.
The marketing authorisations will remain suspended until the conditions which are set out in Annex III https://ec.europa.eu/health/documents/community-register/2020/20201124148388/anx_148388_en.pdf of the EC decision are met by the relevant marketing authorisation holders.
Each marketing authorisation holder is required to carry out the necessary investigations and analytical work to fully address the conditions set out in Annex III; the MHRA will reinstate a marketing authorisation once reassured that all the conditions have been met.
All relevant information communicated to marketing authorisation holders about the suspension of marketing authorisations for ranitidine-containing medicines for human use and conditions for reinstatement of the authorisations can be accessed via the above links to the EC Decision and the relevant Annex.
If you have a query about the information provided, please reply to this email.
If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk
Due to the ongoing Covid-19 pandemic, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.
After that, if you remain dissatisfied, you may write to the Information Commissioner at; The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire
SK9 5AF
They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.
Yours sincerely
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000