REGULATORNE STORITVE
Zajemamo obsežne izkušnje na področju regulative in odlično komunikacijo z regulatornimi organi v Sloveniji. Sodelujemo s številnimi podjetji na območju Evropske unije. Storitve, ki jih nudimo so prilagojene individualnim zahtevam in željam strank.
Nudimo strokovno in poglobljeno znanje regulative na področju:
- zdravila za uporabo v humani medicini (centralizirani postopek, decentralizirani postopek, postopek z medsebojnim priznavanjem, nacionalni postopek),
- zdravila za uporabo v veterinarski medicini (centralizirani postopek, decentralizirani postopek, postopek z medsebojnim priznavanjem, nacionalni postopek),
- medicinske pripomočke,
- kozmetične proizvode,
- prehranska dopolnila,
Na področju regulative nudimo naslednje storitve:
- registracijo novih zdravil po nacionalnem postopku (NP), decentraliziranem postopku (DCP) in postopkom z medsebojnim priznavanjem (MRP);
- vzdrževanje registriranih zdravil: priprava vlog za spremembe in/ali podaljšanje dovoljenja za promet z zdravilom;
- priprave, prevodi in vzdrževanje informacij o zdravilih (priprava in usklajevanje povzetka glavnih značilnosti zdravila (SmPC), navodil za uporabo (PIL) in označevanje ovojnine v slovenskem jeziku);
- preverjanje skladnosti z nacionalno zakonodajo,
- svetovanje na področju nacionalne zakonodaje,
- pripravljamo odgovore na vprašanja nacionalnih regulatornih organov,
- pomagamo pri uskladitvi in pripravi prvotne dokumentacije o zdravilih (označevanje zdravil (zunanja in notranja ovojnina), navodila za uporabo (PIL) in povzetek glavnih značilnosti zdravila (SmPC));
- strokovni pregled promocijskega materiala;
- priprava vlog za odstop od dovoljenja za promet z zdravilom;
- prevajanje in strokovni pregled besedil na področju medicinskih pripomočkov, kozmetičnih izdelkov, prehranskih dopolnil in biocidov.
We have extensive regulatory experience and excellent communication with the National Competent Authorities in Slovenia. We work with a number of companies in the European Union. The services we offer are customized to the individual requirements of our clients.
We offer professional and in-depth regulatory knowledge on the following field:
- Medicinal products for human use (centralised procedure, decentralised procedure, mutual recognition procedure, national procedure),
- Veterinary medicinal products (centralised procedure, decentralised procedure, mutual recognition procedure, national procedure),
- Medical devices,
- Cosmetic products,
- Food supplements.
We offer the following regulatory services:
- Registration of new medicinal products under the national procedure (NP), decentralised procedure (DCP) and mutual recognition procedure (MRP);
- Maintenance of authorised medicinal products: preparation of applications for variations and/or renewal of marketing authorisations;
- Preparation, translation and maintenance of the information on medicinal products (preparation and coordination of the Summary of Product Characteristics (SmPC), the package leaflet (PIL) and the labelling of the packaging in Slovene language);
- Compliance check with national legislation,
- Advice on national legislation,
- Preparation of answers to questions from national regulatory authorities,
- Assist in the preparation of the initial dossier of medicinal products (labelling of medicinal products (outer and inner packaging), package leaflet (PIL) and summary of product characteristics (SmPC));
- Review of promotional material;
- Preparation of applications for marketing authorisation waivers;
- Translation and review of texts in the field of medical devices, cosmetics, food supplements and biocides.
