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Cyprus Drug Product Registration

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Cyprus Drug Product Registration

Safeguarding Public Health Through Comprehensive Regulation

Ministry of Health

Ministry of Health

MoH Website

http://www.moh.gov.cy/moh/moh.nsf/index_en/index_en

Regulatory Agency

Pharmaceutical service

Regulatory Agency Website

https://www.moh.gov.cy/moh/phs/phs.nsf/home_en/home_en?openform

License Validity 

5 years

License Renewal

9 months before the expiration date. EU electronic Application form for Renewals is available at e Submission/EU Electronic Application Forms

Regulation

Medicines for Human Use (Control of Quality, Supply and Prices) law No. 70(Ι),

Fees

https://www.jccsmart.com/e-bill/merchants/4888/outlets/384/invoices/classified 

Overview

  • As a European Union (EU) Member State, the Republic of Cyprus, via the Department of Pharmaceutical Services, requires the submission of medicinal products for human use through the Common European Submission Platform (CESP).
  • The CESP is an initiative applicable to all EU member states, applicants and holders of authorization for veterinary and human pharmaceuticals.
  • The aim is to create a single portal for electronic submissions to various relevant authorities in the context of European registration and post-approval procedures covering, National, Mutual Recognition Procedure (MRP), and Decentralized Procedure (DCP).
  • Since January 1st, 2020, the following activities and applications have been subject to the mandatory submissions through CESP:
  1.  New Marketing Authorization Application (DCP/MRP/National)
  2. Variation Type IA/IB/II (MRP/National)
  3. Line Extension of MA (DCP/MRP/National)
  4. Renewal (MPR/National)
  5. Notifications (National notification/Art.61(3))
  6. Active Substance Master File (ASMF) (Initial submission or variation of ASMF) Responses etc.
  • Yet, there is no requirement for medicinal products authorized through the centralized procedure, marketing authorizations under exceptional circumstances, or parallel importations.
  • Additionally, regulatory activities such as Marketing Authorization Holder (MAH) Transfer, changes in local representation, and modifications to mock-up designs in purely national submissions of MRP/DCP are processed outside the eCTD, and submissions must be electronically provided through CESP.

Marketing Authorization via National Procedure

  • It refers to a Marketing Authorization (MA) that is exclusively valid in the Republic of Cyprus only.
  • Pharmaceutical products that are not marketed in other member states (mostly generics or well-established use medicinal products) and linear extensions of pharmaceutical products (e.g., different strength, route of administration, pharmaceutical form, etc.) that have been approved through a national procedure can both go through the procedure of issuing a National MA.
  • The main types of applications are:
  1. Generic application Article 10(1) according to “The Medicines for Human Use (Quality, Supply and Price Control) Law of 2001.
  2. Hybrid application, Article 10(3), “The Medicines for Human Use (Quality, Supply and Price Control) Law of 2001.
  3. Well-established use application, Article 10a, “The Medicines for Human Use (Quality, Supply and Price Control) Law of 2001
  4. Extension application, “The Medicines for Human Use (Quality, Supply and Price Control) Law of 2001.
    • The medical product dossier must be submitted with the marketing authorization application.
    • The applicant must submit the dossier in Greek or English language, prepared in the electronic form of the Common Technical Document (eCTD).
    • The parts of the eCTD are:
      • Module 1: Administrative data and product information
      • Module 2: Summaries
      • Module 3: Quality
      • Module 4: Non-clinical reports
      • Module 5: Clinical study reports
    • More information regarding Modules 1 to 5 can be found in “EudraLex – Volume 2
    • The eCTD format is mandatory for all new MA applications. This is also applicable to ASMF application submissions.
    • To allow bridging (exemption from submission) preclinical and clinical studies (Sections 4 and 5) for generic applications, equivalency between the generic and reference product must be proved, whereas for well-established use applications A comprehensive evaluation of works published in authoritative journals may be found in Sections 4 and 5.
    • Along with the dossier, the marketing authorization holder must submit a cover letter for application for a marketing authorization, which is signed by the applicant’s responsible/ authorized person and an Electronic Application form for marketing authorization, signed by applicant’s responsible/ authorized person.
    • EU electronic Application form (eAF) for marketing authorization is available at Submisson/EU Electronic Application Forms.
    • A separate individual eAF should be submitted for each pharmaceutical form and strength.
    • All parts of Modules 1, 2, 3, 4 and 5 must be submitted with the application.
    • Depending on the application’s legal basis and specific requirements related to the medicinal product’s pharmaceutical form, individual Module’s content may vary.
    • Marketing authorization application the medicinal product dossier and all other attachments/ documents shall be submitted electronically, via Common European Submission Portal/CESP.
    • Pharmaceutical services specialists who are certified pharmacists must conduct a comprehensive scientific evaluation of a product’s efficacy, safety, and quality before it can be marketed for human use.
    • Upon submission and evaluation of the necessary additional documents, the process concludes with the granting or refusal of a marketing authorization.
  • If, after finalization of the evaluation, a positive opinion is reached on the benefit/ risk balance, the Drug Council after the suggestion of the Subcommittee of New National Products, will issue a decision on granting the marketing authorisation with the approved SmPC, PL, labelling and mock-ups of the medicinal product and the medicinal product will be marketed in Cyprus.

Variation 

  • Once a marketing authorization has been granted obtained, the holder of the authorization is required to submit and inform any modifications to the originally authorized medical product dossier at any point during the product’s life cycle.
  • EU electronic Application form for Variations is available at e Submission/EU Electronic Application Forms.

Marketing Authorization via Mutual Recognition Procedure (MRP) and the Decentralized Procedure (DCP)

The MRP and DCP are EU procedures which lead to the approval of a marketing authorization for a medicinal product which is recognized by a group of Member States of the European Economic Area (EEA).

Decentralized Procedure (DCP)

  • The DCP can be used to obtain a marketing authorization for medicinal products which meet the following requirements:
  1. A medicinal product with the same pharmaceutical, toxicological and clinical documentation is NOT already registered in the EEA with a National or MRP/DCP authorization, and
  2. The applicant for the marketing authorization wishes to obtain a marketing authorization for the same product in at least one other Member State.
    • The applicant selects one of the Member States participating in the procedure to evaluate the product’s dossier and submits identical documents to every Member States involved.
    • Detailed information on the MRP / DCP procedures, guidelines, timeframes and all necessary documentation and standards are available at the CMDh (Coordination Group for Mutual Recognition and Decentralized Procedures) links.
      • Decentralized Procedure Members States’ Standard Operating Procedure
      • Best Practice Guide for Decentralized and Mutual Recognition Procedures
    • Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use” are available at https://ec.europa.eu/health/documents/eudralex/vol-2_en

Mutual Recognition Procedure (MRP)

  • The DCP can be used to obtain a marketing authorization for medicinal products which meet the following requirements:
  1. There is already a registered medicinal product with a national or MRP / DCP marketing authorization with identically the same pharmaceutical, toxicological and clinical documentation in the EEA and,
  2. The applicant for the marketing authorization hopes to obtain a marketing authorization for the identical product in at least one other Member State.

CAP – Centralized Authorization Procedure

  • The CAP application is evaluated by EMA personnel and by the Committee for Human Medicinal Products (CHMP) which consists of one representative and its substitute from each MS.
  • This process only applies to high-tech pharmaceuticals, especially those made using biotechnological techniques, as well as those with new active ingredients and therapeutic uses for conditions including diabetes, HIV, cancer, and neurovegetative disorders.
  • The European Commission grants the marketing permission when the EMA makes a favorable recommendation.

Special Market Authorization

    • Article 126a of European Directive 2001/83, which has been transposed into national law, governs the current procedure and permits the Drug Council to provide special licenses for pharmaceuticals for legitimate public health purposes.
    • Only products without a pending application to the Drug Council or a marketing permission in the Republic of Cyprus are eligible for this type of special permit for medical products.
    • They must also meet the following requirements:
      • The medication has a marketing authorization in an EEA Member State.
      • Copies of the evaluation report and the current marketing authorization for the medication in question may be requested from the appropriate authority in that Member State.
      • Notification is sent to the holder of the marketing authorization in the Member State where the drug in question is approved.
      • The Marketing Authorization Holder shall abide by all provisions pertaining to medicinal products licensed under article 126a Appendix 1 of the European Directive 2001/83, including those regarding the use of the Greek and English languages in labeling, the designation of a Pharmacovigilance responsible person, additional regulations regarding inspections and audits, and regulations regarding immunological medicinal products or products derived from human blood or plasma.
    • License validity: 2 Years.

Renewal: At least 3 months before expiration.

Post Approval Procedures

Renewal Market Authorization Application

  • The Regulatory Sector Reviews Renewal Application which is submitted by the Marketing Authorization Holder to the Drugs Council at least 9 months before the expiration of the current Marketing Authorization (5 years).
  • After the first renewal, the marketing authorization is granted for an infinite amount of time unless the Drug Council renews the license for 5 years based on Pharmacovigilance concerns.
  • A medical product’s license automatically expires after three years if it is not promoted after receiving marketing permission.

Variation Market Authorization

  • According to Regulation (EC) 1234/2008, the Marketing Authorization Holder must submit a variation application to the Drug Council and contain all required documents if one or more data or documents are subject to modification.
  • The Regulatory Sector’s pharmacists, or Assessors, are responsible for reviewing these applications and sending the Drug Council the results of their evaluation.
  • The Drug Council considers the assessors’ report when determining whether to accept or reject the variation application.
  • Linguistic Review in the Greek Language of the Labeling [ie. Summary of Product Characteristics (SmPC) and, Patient information Leaflet (PL) – Quality Review of Documents
  • The pharmacists who are assessors in the drug regulatory sector conduct a linguistic review of the GreekSmPC, the patient information leaflet and the Greek labeling.
  • The Assessors also actively contribute to the linguistic review of the Greek translation of medicinal products subject to centralized authorization procedure throughout participation to the Quality Review of Documents Group of the European Medicine Agency (EMA).
  • To reduce the risk of transmission of transmissible spongiform encephalopathy (TSE), the control of pharmaceutical products with animal origin components
  • Pharmacists (Assessors) of the Regulatory Sector conduct the control of Pharmaceutical Products with animal origin excipients.
  • The Marketing Authorization Holder submits the European Pharmacopoeia (CEP) Certificate of Suitability for all raw materials of animal origin subject to examination by the Drug Regulatory Sector Assessors.

Cyprus as RMS

  • Cyprus has assumed the role of Reference Member State (RMS) from January 1, 2020, in the process of issuing marketing authorizations through the Mutual Recognition Procedure (MRP) and the Decentralized Procedure (DCP).
  • The MRP with Cyprus as the Reference Member State (RMS)s only valid for products which already have a marketing authorization in Cyprus, and which intend to obtain a marketing authorization in another Member State.
  • In the case of products that do not have a marketing authorization in the European Union and for which the marketing authorization holder wishes to obtain a marketing authorization in more than one Member State, the decentralized procedure is applicable.
  • The interested parties are asked to submit their requests as soon as feasible on their purpose and the reservation of slots to better organize the available resources and planning.
  • The applicant gets an email within 30 days either approving or rejecting their request. A new slot request must be submitted for any changes made to the original request (such as changing the product, pharmaceutical form, or content).
  • The information above also holds true in cases when the candidate chooses to adhere to the MRP and RUP procedure. The form may be accessed at the following URL on the CMDh website: https://www.hma.eu/481.html
  • Before requesting an MRP/RUP slot request, the dossier of the medicinal product must be updated.

MRP/DCP With Cyprus as RMS

Submission Intention and Reservation of Submission Date (Slot request)

    • The applicant informs the Medicines Council by submitting a slot request no sooner than 18 months prior to the submission date that he is interested in registering a certain product via the DCP procedure with Cyprus as RMS.
    • The form is available on the CMDh website at https://www.hma.eu/219.html
    • The correctly completed should be submitted to the email rmscyprus@phs.moh.gov.cy 

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