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What we can offer you

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:

  •  We will be dedicated to your company providing personalised services
  • We will listen and understand your needs
  •  We will give you valuable information on the Greek Health environment making you understand the local barriers and requirements. 
  • We will review your data and collaborate with you in making the business plan to be followed, including: 
  •     The strategic decisions to be taken based on realistic assumptions on timelines and expected outcomes
  •     An implementation plan according to agreed timelines.

  •  During our collaboration we will provide you with reports on the progress of the project on a regular basis.

  • We will proactively take measures to avoid issues, especially those that can be predicted.
  • We will resolve any unpredictable problem that could arise during the implementation phase.
  • Finally, we will offer you our services at a reasonable cost.


Services

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:

  • Medicinal & Veterinary products
  • Registration procedure
  • Pricing
  • Reimbursement
  • Consultation on strategic decisions
  • Compliance with Pharmaceutical Legislations
  • Pharmacovigilance (via specialized partner)


Regulatory Affairs

  • Compilation of dossiers for MAAs and Life cycle management submissions to National Drug Organisation.
  • Negotiations and influencing activities
  • Creation and compliance of packaging materials
  • Promotional Materials compliance


Pharmacovigilance – via partner

  • Reporting Requirements
  • Submission of SUSARS and PSURs
  • Reporting of Spontaneous AERs occurring in Greece/Cyprus
  • Local QP
  • Local literature searches


Market Access

  • Price applications and negotiations
  • Reimbursement applications and negotiations 


General Consultation Services

  • Pre submission advice with regard to registration, pricing and reimbursement strategy and requirements, as well as expected timelines for each procedure.
  • Assistance on Greek specific regulatory requirements with regard to imports, distribution, authenticity labels, sales reporting etc., as pre work for the establishment of a company’s business in Greece.
  • Regulatory intelligence / Competitor information / Thorough information on the Greek Health Environment and any new development


Food supplements

  • Evaluation of the permissibility of the ingredients in the product

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.

  • On-line registration of the local distributor to the EOF’s website
  •  Preparation of the product notification file by collecting all the necessary documents
  • Creation of greek labeling texts according to the labeling requirements for food supplements
  • Uploading of documents to the EOF’s e-platform and submission of product notification both electronically and as hard copy with the required documents.
  • Follow up of the notification procedure with the EOF
  • Review the advertising campaigns of the food supplements in order to comply with the local requirements
  • Import license for importing products from 3rd countries


Cosmetics

  • On-line registration of the local distributor to the EOF’s website
  • Distributor notification to the CPNP • Labeling requirements
  • Import license for importing products from 3rd countries Medical Devices
  • Preparation of the product notification file by collecting all the necessary documents and submission of product notification to the EOF competent department
  • Preparation of greek labeling texts