Supplying Health

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

Named patient program

Named Patient medicines provide the access to patients and physicians to commercially approved medicines that are not available to them in their own country. These medications must be approved in at least one country, from which it can be imported into the patient’s country under the NPP program.

In cases when medication/drugs are:

• Approved but not yet commercially available to be prescribed in the patient’s country
• Approved and available in one country but not approved and available in the patient’s country
• Discontinued in the patient’s country but not another
• In shortage in the patient’s country but not another

Market Access

• National pricing/reimbursement
• Local negotiations or prescribing guidelines

We ensure that patients get the proper treatment and benefit from rapid and maintained access to medicines at the right price.

Orphan drugs program

Rx Pharma has attained a significant role in orphan drugs supply, as their sales have skyrocketed in recent years. We were happy to provide help for thousands of patients in EU. If you have any requests, our dedicated team of both medical and regulatory experts with practical experience and deep knowledge of this challenging sphere will be ready to help.