Regulatory affairs services
Preparation of Applications and files for:
- Granting marketing authorization (via national, DCP and MRP procedures)
- Renewal of marketing authorization
- Variations type IA, type IB, type II
- Changing the classification for the supply of a medicinal product
- Transfer marketing authorization
- Changes of labels and/or patient information leaflets (Article 61(3))
- Granting marketing authorization for parallel import
- Variation for parallel import
- The common Baltic package procedure
- The common Polish and Lithuanian labelling procedure
- Granting marketing authorization for homeopathic medicinal product according to Article 14 and 16.2 of 2001/83 (EC Directive)
Review and modify SmPC, package leaflet, labelling texts and Mock-ups of the labelling texts
Monitoring of regulatory submissions
Submission of PSURs
Preparation, review and submission for approval of additional labels (stickers)
Representation of the marketing authorization holder in Lithuania
Review and submission of marketing material for approval
Notification of food supplements, foods for special medical purposes
Registration of medical devices
Pharmacovigilance services
Management of pharmacovigilance data
Procession of suspected adverse reactions (ARs) and follow-ups (collection, translation and forwarding of information to MAH)
Reporting of adverse events / reactions to Lithuania competent authorities
Literature monitoring
Monitoring of local literature on adverse events
Performance of medical devices vigilance
Additional services
Acting as a local contact canter for Lithuania‘s health authorities
Consulting partners regarding pharmacovigilance and regulatory activities in Lithuania (management of budget, time-lines and submission planning)
Update on changes of local legislation