This Reed Smith client alert looks at the recent amendments to the Human Medicines Regulations 2012, which came into force in November 2013.

Executive summary

On 11 November 2013 the Human Medicines (Amendment) (No.2) Regulations 2013 (the “Amendment”), which amends the Human Medicines Regulations 2012 (the “Regulations”) came into effect. The Amendment implements Directive 2012/26/EU and Regulation (EU) No 1027/2012 setting out changes to the licence notifications that holders of marketing authorisations must give and changes to pharmacovigilance monitoring systems. The Amendment allows General Sale List (“GSL”) medicines (often referred to as Over-The-Counter medicines or “OTC medicines”) to be sold on trains and aeroplanes in the UK.

Background

The original European legislation currently provides a regime for, amongst other things, the authorisation of medicinal products for manufacture, import, distribution, and for pharmacovigilance. The overriding aim of the regime is to protect public health by ensuring that medicines meet necessary standards of safety, quality and efficacy. In the UK, this regime is implemented by the Regulations.

The Amendment includes a change to the notification requirements of holders of UK marketing authorisations to the licensing authority, amendments to the current pharmacovigilance systems, and approval for the sale of GSL medicines on trains and aircraft.

The Amendments

Licence notification

There are several changes set out in the Amendment, including a change to the notification requirements of holders of UK marketing authorisations to the licensing authority (i.e. the MHRA) where the holder takes action to:

1. Request the cancellation of the authorisation
2. Not apply for the renewal of the authorisation
3. Withdraw the product to which the authorisation relates from the market in a third country (whether temporarily or permanently) and the action is based on any ground set out in Article 116 or 117 (1) of Directive 2001/83/EC (these articles deal with products which are harmful, have low efficacy or their composition is not as declared)

An identical amendment has also been made for holders of a traditional herbal registration.

Under the Regulations, pharmaceutical companies already had a duty to notify the licensing authority if they intended to withdraw a product from the market. Under the Amendment, a company must provide a reason for this removal. The Amendment also introduces a new duty whereby companies have to inform the licensing authority where a licence is not renewed and provide a reason.

Pharmacovigilance

There are also changes to the procedure relating to pharmacovigilance systems for monitoring the safety of medicines.

Under the Amendment, the licensing authority must inform the European Medicines Agency and Member States where, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, it considers it necessary to vary an authorisation, or registration, or a class of authorisations, or registrations. If a safety issue is identified in one EU country, a coordinated action is taken in all Member States where a product is marketed. The UK supported the proposals and considered that their effect did not materially alter the current safeguards in place across Europe.

Sale of GSL medicines

The Amendment also introduces a change which permits the sale of GSL or OTC medicines on planes and trains. In order to comply with the new rules, the product must:

1. have been made up for sale or supply in a container at a place which is not where it is sold or supplied; and
2. be stored in a part of the aircraft or train which the operator is able to close so as to exclude the public.

For this part of the Amendment there was an informal consultation with industry members. Whilst there were some dissenting views, the majority of respondents to the consultation were supportive of the changes. However, queries were raised over the demand for this change, the practical limits to the range of medicines which could be carried on a plane or train, and the fact that medicines are already available for emergency use on planes and trains.

Although GSL medicines are widely available from other sources, such as newsagents and supermarkets, the ability under the Amendment to sell these products on long- and short-haul travel opens a new outlet for companies.

A full copy of the Amendment can be found here and a guidance note produced by the MHRA can be found here.

Client Alert 2013-325