EU (FMD) Pharmaceutical Packaging
What is the Falsified Medicines Directive?
The European Parliament and Health Council the Falsified Medicines Directive has begun to introduce stronger rulers so that the population health is not brought into disrepute. EU guidelines regulating pharmaceutical packaging are getting a lot stricter, new legislation and measures are being introduced to guarantee that medicines and their packages will become heavily policed.
Why Is It Coming into Force?
Fake medicines are a major issue within the pharmaceutical industry and are becoming harder to detect. Falsification methods of manufacturing medicines are becoming more sophisticated which is allowing counterfeit drugs to pass through the net of legislation.
Pharmaceutical products and drugs that end users are consuming may have the wrong ingredients, have not been evaluated to pass the quality and efficacy of the drug (EU authorisation procedures). The proliferation of falsified medicines is a big threat to the health of the global population and with the new 2019 EU Directive on Anti-counterfeiting, the problematic issue with counterfeit drugs is set to be eradicated.
What are the Regulatory Aspects?
Directive 2011/62/EU introduces obligatory “safety features” for pharmaceutical packaging – a unique identifier and an anti-tampering device – to allow the verification of the authenticity of medicinal products subject to prescription and protect patients and business alike from the risks of falsified medicines. The Directive places the Commission under an obligation to adopt a delegated act setting out the details of the safety features, including how medicine authenticity should be verified and by whom.
Falsified Medicines Directive UK Implementation
Origin can offer you guidance and help you with quality assurance and risk assessment to ensure you pharmaceutical packaging meets material specifications and stability and design requirements to satisfy the EU directives and pharmaceutical compliance packaging rules. With the implementation of Brexit its especially important that British businesses understand the impact, and how they will be affected by the rules governing the packaging of medicinal products in the European Union.
Origin is Here to Help
Let Origin be your partners consult with us and let us help you find solutions and understand the EU Falsified Medicines Directive European legislation, regulations, guidelines, legal design requirements, and how UK companies can be compliant with new pharmaceutical packaging quality control safety features and the MHRA.
