Kick-off meeting of the Latvian Medicines Verification System together with Arvato
More than 140 participants participated in the meeting: representatives of producers, the medicines of which are subject to the requirements of the Falsified Medicines Directive, as well as representatives of pharmaceutical wholesalers, pharmacies, hospitals and other health institutions, who are responsible for the affairs of introduction of the Delegated Regulation in the particular health care institution.
In the 1st part of the meeting Jānis Zvejnieks, the Deputy Director of the State Agency of Medicines (ZVA), told about:
- the regulation on mandatory safety features for medicines
- about the model and structure of medicines verification system
- about notification on the inclusion of the planned unique identifier in the labelling of medicines
ZVA invites the owners of certificate of registration to introduce safety features by combining them with other changes that are related to product information or re-registration. Participants of the meeting were informed also about planned changes in the national legislation.State Agency of Medicines
Inese Erdmane, the Chairman of the Board of LZVO, informed participants of the meeting about foundation of the society, purposes, tasks and current works. Participants were introduced with the current and planned contractual relations, funding principles of the society and mutual cooperation.
Olle Hamskär, the Regional Manager of Arvato, introduced with the company, its history, customers, projects and countries, with which the agreement on the establishment and maintenance of the national medicines verification systems was concluded.
Tim Mackeldey, the Project Manager of Arvato in Latvia, told about the Latvian company and functions thereof for the implementation of medicines verification system in Latvia.
In the 1st part of the seminar Tim Strässer, the National Medicines Verification Organisation Adviser of Arvato, introduced with the plan of the project and works to be performed by each in order to introduce the verification system in a timely manner and to be ready to authenticate medicines as of 9 February 2019. In the second part of the seminar the suppliers/ providers of IT systems for pharmaceutical wholesalers and pharmacies and IT software for hospitals and other health institutions were informed about the portal, where IT software suppliers for medical institutions will be able to register in order to receive informative materials and to commence the adjustment of their internal IT systems. And finally the package of technical documents were showed that will have to be acquired and performed by IT software suppliers or providers for local medical institutions.
On behalf of LZVO and all lecturers I would like to thank all participants for active participation and questions asked. Let’s continue the commenced cooperation in order to prepare for implementation of the requirements of the Delegated Regulation in Latvia in a timely manner.