Our agency can handle the entire process and the necessary administrative steps in bringing a medical product to the market. We provide consultation, help with the preparation, sort it out for you.
Regulatory Affairs Services
Do you need a representative to work with local health authorities on your behalf in preparation and implementation of all regulatory procedures? We ensure registering of your human medicines and medical devices in the Slovak Republic and take care of your product throughout its entire life cycle.
- Registration of medicinal products – All types of registration procedures (national registrations, MRP, DCP), preparation and submission of documentation for registration of medicinal products, variations, renewals, transfers of marketing authorisations, cancellation of registrations – submissions via CESP and national portals.
- Registration of medical devices, food supplements and cosmetics – preparation of documentation and submission to the competent authorities.
- Local contact for communication with authorities – strategic contacts to national health authorities, acting as authorised representative for EU manufacturers.
- Checking texts and documentation for compliance with legislation – keeping up to date with national legislation and guidelines.
- Professional translation of texts – translation of SmPC, PIL and LAB texts from EN to SK in accordance with EU requirements and QRD templates.
- Post-registration support – sunset clause monitoring, validity of certificates for medical devices.
- eCTD format – dossier processing in eCTD format.
- And other services….. – Proofreading, handling of exemptions for import of foreign language packs, registration of medical device distributors, consultations…
Pricing and reimbursment of medicinal products
(medicines, MDs, SMMs and dietetic foods)
The process of pricing and categorisation is an essential part of ensuring the availability of a medicine (medicinal product) on the Slovak market and its reimbursement by health insurers. At IQ-MED we manage these processes in accordance with the applicable legislation and methodological guidelines.
In the area of categorization and pricing we provide the following services:
- preparation of price analyses for the entry of a medicines (medicinal product) on the market
- formal representation before the institutions of drug policy
- daily monitoring of proceedings on the electronic Categorisation portal of the Ministry of Health
- preparation of documentation for all types of proceedings
- preparation of all types of applications for inclusion of a medicinal product (submitted via the Categorisation portal)
- referencing - tracking EU prices, preparing analysis and submitting documents
- processing comments on proceedings and objections to decisions
- preparing an overview of upcoming changes to the Categorisation List on a monthly basis
Pharmacovigilance is the surveillance of adverse medicinal product reactions and ensuring the highest possible safety of medicines in clinical practice. The pharmacovigilance system also establishes measures to minimise risks to the safety of medicinal products.
In the area of pharmacovigilance we provide the following services:
- We act as the local qualified person for pharmacovigilance (LSO) and his/her deputy.
- 24/7 pharmacovigilance on-call duty
- Communication with the national authority (ŠÚKL)
- Informing the holder about changes in pharmacovigilance legislation
- Communication in Slovak language with the national authorities and in English with the registration holder he/she represents.
- We maintain and archive pharmacovigilance-related documentation and ensure literature monitoring
- We provide initial and ongoing training programmes for all staff on pharmacovigilance (GVP).
Expert advice on the advertising of medicinal products
We provide advice, consultation and legislative review of advertising materials for medicines, food supplements, medical devices and cosmetics.
- Are you preparing a medical product advertisement and don't know how to go about it?
- Not sure how to communicate with professionals and the general public?
- How to deal with the compliance of your advertisement with the SmPC?
- Need help with advertising at congresses?
- We will be happy to advise you on compliance with the Medicinal Products Act and the applicable regulations.
Expert advice for the distribution licenses
We provide consultation and help with the preparation of applications for handling licenses for the wholesale distribution of medicinal products for human use.