News Category: Regulatory news
On 12 September 2019, the European Commission triggered a referral procedure under Article 31 of Directive 2001/83/EC and requested the CHMP to start a review of ranitidine containing medicines. This was because tests showed that some of these products contained an impurity called N-nitrosodimethylamine (NDMA).
The Article 31 referral review of ranitidine containing medicines by the CHMP concluded fully on the 17 Sept 2020 with CHMP recommending a precautionary suspension of ranitidine containing medicines in the EU. The EMA also recommended conditions for lifting the suspension of ranitidine medicines, including requirements for companies to provide more data.
Detailed of this review and associated decision can be accessed at this link.
The CHMP opinion, having been forwarded to the European Commission, is now subject to a final legally binding Commission decision of 24 November 2020 applicable in all EU Member States. The HPRA is required to complete this action as per the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2019 (S.I. 540 of 2007, as amended) by 24 Dec 2020.
The terms of this suspension allow for the HPRA to deem particular medicinal products as critical and therefore to defer the suspension for up to 12 months. The HPRA shall support the deferral of suspensions in the following cases:
- IV formulation for the ‘short term treatment of peptic ulcer’ in paediatric patients aged 6 months to 18 years due to the lack of available/authorised proton pump inhibitors (PPIs) for use in children younger than 1-year of age.
- Oral Solution/Syrup for the ‘short term treatment of peptic ulcer’ in paediatric patients with percutaneous endoscopic gastrostomy (PEG) due to the lack of available/authorised alternatives.
It is important to note that many ranitidine containing medicines have not been available in the EU for several months. This is because national authorities have recalled them as a precaution while the EMA review was ongoing.