The recent news of the withdrawal of pholcodine from certain cough medicines has sent shockwaves through the medical industry.

The BBC recently reported that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has ordered the withdrawal of certain cough medicines containing the active ingredient pholcodine; issuing a warning to all manufacturers of this product that they will need to re-apply for licensing after re-formulating their products.

The move comes after an MHRA review found that pholcodine could cause rare but serious side effects, including allergic reactions and breathing difficulties.

Pholcodine is an ingredient that had been used in some cough syrups to reduce the severity of a cough. However, the MHRA found evidence that the ingredient was not effective at this task and had the potential to cause harm when used in high doses.

The affected medicines are sold over-the-counter in pharmacies, supermarkets and other retail outlets. It is important to note that this decision does not apply to all medicines containing pholcodine. Only those medicines specifically mentioned in the MHRA’s announcement are affected.

The MHRA has asked manufacturers to recall all medicines containing pholcodine. This means that manufacturers will need to re-formulate their products to remove pholcodine and then re-apply for licencing to the MHRA to ensure they are compliant with the MHRA’s requirements.

The re-formulation process, and the subsequent re-licensing process, can be a lengthy and complex process. Manufacturers of cough medicines containing pholcodine will need to ensure that their products meet all of the regulatory requirements before they can be re-licenced. This may require additional resources and expertise, which can be difficult to obtain.

Fortunately, there are regulatory agencies with the resources and capabilities to support manufacturers through this process. Woodley BioReg offers a wide range of services, from regulatory advice and support to product registration and licensing. The company provides manufacturers with access to the latest regulatory information and guidance, helping them to stay up to date with the latest regulatory requirements.

If you are looking for a partner to help you obtain regulatory approvals, please contact us to discuss how Woodley BioReg can be of assistance. We look forward to hearing from you.

Contact us

Back to News + Insights