Regulatory Affairs
Eletis Medica has more than 20 years of experience in regulatory affairs services. It allows to select the right registration strategy for medical products (generic, hybrid, OTC, herbal and/or well established use applications) as well as coordination and management of the procedure.
Eletis Medica offers all range of registration services for medicinal products in Lithuania, Latvia and Estonia. Starting from the evaluation of pre-registration dossier, generation of additional documentation, submission an application, product registration and post-marketing surveillance.
We can provide you with the following services:
- Registration procedures for National (NL) medicinal products;
- Registration procedures for Decentralised (DCP) medicinal products;
- Registration procedures for Mutual Recognition (MRP) medicinal products.
Strategic plan of registration procedure
The strategic plan for marketing authorisation is as follows:
- Selection and justification of application type in accordance with national legislation and EU guidelines;
- National (NL) marketing authorisation procedure;
- Decentralized (DCP) marketing authorisation procedure, as concerned (CMS) or reference (RMS) member state;
- Mutual recognition (MRP) marketing authorisation procedure, as concerned (CMS) or reference (RMS) member state;
- Linear extension of marketing authorisation.
Pre-submission assessment of the dossier
Twenty years of registration experience has shown that half way to successful marketing authorisation is proper pre-submission assessment (audit) of the dossier and documentation adjustment according to experts’ notes. We offer and advise to use an objective and scientific pre-submission assessment of your dossier. We can perform pre-submission audit and completeness of the dossier in order to save your money and time for authorization procedure.
Documentation preparation for medicinal product registration
Preparation of documents for the registration procedures of all kinds of medicinal products, i.e. renewals of variations, marketing authorisation and registration.
Eletis Medica is able to offer:
- Creation and completion of entirely new medicinal product dossier for marketing authorisation procedure, it is a complete administrative Module 1, the qualitative part (Module 2.3), prie-clinical (module 2.4/2.6), clinical (module 2.5/2.7) review and summary, 3 4 and 5 modules;
- Update of the summary of the case (from NTA format to CTD format).
eCTD files preparation
Eletis Medica uses a French software eCTD for the development of electronic dossier, which is mandatory for decentralized (DCP), Mutual Recognition (MRP) procedures and in many EU countries for the national (NL) procedures as well.
We offer to convert your paper (CTD) files to an electronic (eCTD) dossier, the validation and management of the following documents:
- Registration of medicinal products;
- Renewals;
- Variations.
Package leaflet readability test
Readability test of package leaflet is an accurate assessment of your package leaflet, which is based on the data obtained through a two-stage leaflet readability test, involving not less than 20 volunteers, whose data and questionnaires are stored in JSC Corpus Medica archives and could be provided on request of the State Drug Control Agency (SMCA).
The protocol of readability test can be used not only in Lithuania, but in all European (EU) countries as well, since the Customer receives the protocol in English (EN) language.
The readability test of package leaflet is prepared according to the European Commission Guidelines ”Guidelines on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human use“ Revision 1, 12 January 2009.
Dossier submission for registration
Corpus Medica offers not only the creation of medicinal product and review of the documentation for marketing authorisation, renewal and variation procedures, but also
the mediation and management of the procedure:
- Marketing authorisation (MA);
- Renewal;
- Variation.
Post-approval period
- Post-approval period is control and management of your medicinal product-related marketing authorization (MA) rights in collaboration with the manufacturer and State Medicine Control Agency (SMCA). These are the variations of marketing authorisation according to the national law and European legislation.
- JSC Corpus Medica offers to take care of your responsibilities, as the Marketing Authorisation Holder (MAH) in the maintenance and development of marketing authorisation rights.
Medical device registration
- Medical device notification;
- Preparation of medical device documentation for the CE certification;
- Preparation of medical device dossier.
Registration of cosmetic products
- Preparation of labelling information for cosmetic product;
- Notification of cosmetic product;
- Preparation of cosmetic product information file;
- Safety assessment of cosmetic products and preparation of safety report.
Food supplement notification
- Preparation of labelling information for Food supplement;
- Notification of Food supplement;
- Consultation concerning Food supplement composition.