Although the registration procedures for obtaining Marketing Authorisation of medicinal /veterinary products/cosmetic products and medical devices in each EU country are harmonized, there are still very important local barriers to overcome and numerous local requirements to be met for obtaining access of your products into each market. Among them are the pricing and reimbursement criteria, hospital formularies, food supplements approvability, delays in the issuing of licenses, regulations on promotional expenses and a number of other measures that are taken in national level by the government in order to contain the increasing pharmaceutical bill. At Croma , your Regulatory Affairs Partner in Greece and Cyprus, we have thorough and detailed knowledge of the Greek and Cyprus Healthcare Environment, excellent relations with key stakeholders and experts and in-depth understanding of the inner working of the Health Authorities. You can find in us the partner that, in collaboration with you, can break these barriers enabling the ACCESS OF YOUR PRODUCTS INTO THE GREEK MARKET.
We will work with you as follows:
- The strategic decisions to be taken based on realistic assumptions on timelines and expected outcomes
- An implementation plan according to agreed timelines.
Croma is providing the services listed below, working personally and closely with its partners striving to achieve the best results in relation with set priorities and within the set time frames.
CROMA’s services include:
Pharmacovigilance – via partner
General Consultation Services
Although the European Union has taken steps to harmonise the regulation of nutritional supplements including vitamins and minerals, across the EU, there are no specific rules regarding the prohibitions or restriction of use of ingredients such as herbal substances, amino acids, enzymes, prebiotics etc. In the absence of specific rules regarding prohibition or restriction of use of substances other than minerals and vitamins, relevant national rules apply for the range of products containing these kind of ingredients.
Croma supports its clients by evaluating the permissibility of the ingredients of a food supplement, prior to the submission of its notification to the EL Health Authorities.