CROMA Services

What we can offer you

Although the registration procedures for obtaining a Marketing Authorization for medicinal products for human and veterinary use in EU countries 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, national authorities’ procedures and delays in the issuing of licenses, regulations on promotional expenses and a number of other measures that are taken on national level by the government, in order to regulate and constrain the increasing pharmaceutical bill.

For Food Supplements, Food for Special Medical Purposes, Biocides, Medical Devices, In Vitro Diagnostics and Cosmetics the national requirements remain still hugely different among countries of the EU, thus making it absolutely necessary to have strong knowledge of the national legislation and the procedures set by the Competent Authority.

We, at CROMA, your Regulatory Affairs Partner in Greece and Cyprus, 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 any barrier to enable the ACCESS OF YOUR PRODUCTS INTO THE GREEK AND CYPRIOT MARKET.

This is how we will work with you

  • We will be dedicated to your company providing personalized 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.
  • We will offer you our services at a reasonable cost.

Services

CROMA is providing the below listed services, 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 Products
for Human and Veterinary use

Registration and Regulatory Affairs

Registration procedure

eCTD/VNeeS publishing

Compilation of dossiers for MAAs and Life cycle management submissions to National Drug Organization.

Consultation on strategic decisions.

Compliance with Pharmaceutical Legislations.

Negotiations and influencing activities.

Creation and compliance of packaging materials

Promotional Materials compliance

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.

Market Access

Price applications and negotiations

Reimbursement applications and negotiations

vaccine

Pharmacovigilance – via partner

Reporting Requirements

Submission of SUSARS and PSURs

Reporting of Spontaneous AERs occurring in Greece/Cyprus

Local QP

Local literature searches

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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 kinds 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 and by informing them on any national restrictions, where applicable.

Food Supplement Notifications, Labelling creation and Review of Promotional activities

  • On-line registration of the local distributor/company responsible for marketing to the EOF’s platform.
  • Preparation of the product notification dossier 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 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.
  • Application for the issue of Free Sales Certificates for the export of the products to non-EU countries

Food for special medical purposes
(FSMPs)

  • On-line registration of the local distributor/company responsible for marketing to the EOF’s platform.
  • Preparation of the product notification dossier by collecting all the necessary documents.
  • Creation of greek labeling texts according to the labeling requirements for food for special medical purposes.
  • Uploading of documents to the EOF’s 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.
  • Application to EOF for the inclusion of food for special medical purposes into the EOPYY list for reimbursed products.

Cosmetics

  • On-line registration of the local distributor to the EOF’s platform.
  • Distributor notification to the CPNP.
  • Labeling requirements.
  • Import license for importing products from 3rd countries.

Medical Devices
& In Vitro Diagnostic Medical Devices

Registration in EUDAMED

Consultation on the procedure to be followed in Greece and Cyprus

For Greece:

On-line registration of the local distributor to the EOF’s platform.

Preparation of the product’s notification file by collecting all the necessary documents and submission of product’s electronic notification to the dedicated EOF’s platform (GREMDIS). Preparation of greek labeling texts and Instructions for Use.

Submission of Free Sales Certificate or a Proof of the Product’s Notification application in GREMDIS.

For Cyprus:

Preparation and submission of product’s notification file to CYMDA. Submission of a Free Sales Certificate issuing application

Biocides

Consultation on the procedure to be followed for the registration of a biocide dossier in Greece.

Collection of all necessary documents, preparation and compilation of the dossier (short or full dossier) and submission to EOF when the product fulfils the requirements for a national registration procedure.

Compilation and submission of Renewal and variation dossiers for registered biocide products.

Regulanet – Our Network

Since 2008 CROMA is a full member of an international Regulatory CRO network, “Regulanet”, which undertakes international and novel projects, executed via a selected group of experienced and established quality local expert companies.

Services

Full range of Regulatory Affairs related services

  • Strategic Advice
  • Pharmaceutical Development
  • Preclinical Development
  • Clinical Strategy & Development
  • Project Management
  • Regulatory Strategy & Implementation
  • Pharmacovigilance
  • Data Science & Analytics
  • Market Access
  • Portfolio Analysis & Life Cycle Management
  • Due Diligence
  • QM Systems, Licenses & Compliance
  • Data Protection
  • Brexit