Pharmacovigilance legislation in the European Union (E.U.)
The European Union (E.U.) has adopted numerous laws in order to strengthen its position and act as a governing body for those countries under its umbrella. One such area in which this is happening is through a Regulatory scheme which has been in place in the United Kingdom for many years – ‘The Black Triangle Scheme ‘. This scheme is used to monitor the safety of New Medications and Vaccines throughout all EU member states.
The scheme focuses on medications which are being monitored particularly closely due to the fact that relatively little information is known about them outside of clinical trials; for example it may have been placed on the market only recently.
New medications to the market may have only recently finished clinical trials involving relatively small groups of selected individuals who take the medication for a relatively short period of time and may not be fully representative of the consumers who will ultimately purchase or be prescribed this medication. However, this by no means implies they are unsafe.
Some of us may have seen the 1966 movie ‘Fantastic Voyage’ where a team of doctors was miniaturised and injected into a man to operate on a blood clot in his brain. This movie, although farfetched, showed a futuristic glimpse into the capabilities and applications of nanotechnology.
One of the most promising applications of nanotechnology is in Nanomedicines. Nanomedicines can be defined as the application of nanotechnology to medical diagnostics, therapies and prevention. The future applications of nanomedicines will involve engineered molecules to develop drugs, drug delivery systems, diagnostics, medical devices and advanced gene therapy and tissue engineering procedures.
Resolving issues in relation to public health or community interest
The Committee for Medicinal Products for Veterinary Use (CVMP) is responsible for preparing opinions on behalf of the European Medicines Agency (EMA) for any issues or questions regarding veterinary medicines. The CVMP referral procedure is used to resolve any issues that may be raised in relation to a veterinary product’s impact on public health or in cases where community interest is called into question.
A referral can be initiated for a number of reasons, as outlined below, under EU pharmaceutical legislation for veterinary medicines (Directive 2001/82/EC, as amended):
Most Common referrals:
Article 33: Mutual-recognition procedure (MRP) and decentralised procedure (DCP) referral
Article 34: Divergent decision referral
Article 35: Community interest referral