The purpose of the forum is to have an informal discussion with the pharmaceutical industry, pharmaceutical supply chain, pharmacies and NMVO. Based on the impact and the changes to be made, in order to accommodate all the provisions within the Delegated Act, it is important to have the articipation of the entire supply chain to discuss these challenges and gain a better understanding of everyone’s needs, expectations and concerns.
We expect around 100 participants from pharmaceutical companies, equipment manufacturers, distribution- and packaging companies. Workshops will be held in the afternoon. The day will be covered by the press.
The European Parliament adopted in 2011 a comprehensive EU directive on Falsified Medicines Directive (2011/62/EU), to prevent counterfeit medicines from entering the legal supply chain. The key aspects of this directive is the requirements on the safety features for medicinal products for human use. This applies to prescription medicines and select Over-The-Counter drugs, distributed to patients in the EU, to carry a serialised Unique Identifier within a 2D datamatrix barcode and an anti-tampering device. Each Member State must also deploy an authentication system for the verification of the Unique Identifier at the point of dispense without interfering with professionals’ daily activities (distribution, hospital or community pharmacy).
Different instances of the industry, and the pharmaceutical supply chain, have requested a forum for discussion and exchange of knowledge due to the EU legislation and the readjustment this will mean for all parts of the industry.
The European Commission have recently (Oct 2, 2015) adopted the Delegated Act (DA) on safety features for medicinal products, the document was also published on their webpage in August. The DA, defines the roles and responsibilities each and every participant engaged in the manufacturing, distribution, parallel trading, dispensing medicinal products and regulatory. The next step, following the adoption of the DA, will be a Publication in the Official Journal of the European Union. After that the clock starts ticking as it there is a three years’ time limit to implement the requirements of the Delegated Act and be fully compliant. The official publication date is not disclosed yet but is expected to happen in mid-February 2016.
The purpose of this event is to have an informal discussion with the pharmaceutical industry, pharmaceutical supply chain, pharmacies and NMVO. Based on the impact and the changes to be made, in order to accommodate all the provisions within the Delegated Act, it is important to have the participation of the entire supply chain to discuss these challenges and gain a better understanding of everyone’s needs, expectations and concerns.
Around 100 participants are expected from pharmaceutical companies, equipment manufacturers, distribution- and packaging companies
