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Our services

CZ Pharma provides comprehensive pharmaceutical services related to placing products in the Central European market. Our market analysts, employees of the department of drug registration and pharmacovigilance, and colleagues from logistics and marketing help our business partners to transport products from their laboratories primarily to the Czech and Slovak markets. CZ Pharma holds all the relevant permits and certificates for the services offered.


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Pharmaceutical marketing

  • analysis of data of the selected pharmaceutical market, forecasting of sales of a particular drug or medical device in the selected time horizon after entering the market,
  • selection of market entry strategy: under own brand (the producer remains the marketing authorisation holder) or by selling a licence to CZ Pharma and entering the market under the Olikla® brand,
  • selection of marketing activities during and after placing the product in the selected market,
  • monitoring of ongoing tenders for medical devices, including management of the selection process agenda, and negotiation of terms and conditions with pharmacy chains,
  • services of medical representatives.

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Regulatory Affairs – Registration Services

Drugs

  • initial audit of the dossier of the drug being registered,
  • choice of the drug registration strategy: NP (national registration), MRP (mutual recognition procedure) or DCP (decentralised procedure), ensuring DCP slots with the State Institute for Drug Control when the reference country is the Czech Republic,
  • entire management of the registration process by our registration department: artwork of mocaps, SPC, PIL, readability testing, creation and submission of an application in the eCTD format, payment of administrative fees for the registration,
  • post-registration surveillance: changes in the registration, registration renewal, creation of periodic safety update reports (PSUR),
  • creation of application and determination of prices and reimbursement of the products, including listing in health insurance companies' code lists.

Medical Devices

  • initial audit of the documentation for the medical device being registered,
  • notification (registration) of the medical device with the State Institute for Drug Control,
  • listing of the product in the health insurance companies' code lists, including arranging reimbursement from health insurance companies.

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Pharmacovigilance Services

As a marketing authorisation holder for drugs under the Olikla® brand, CZ Pharma has its own in-house pharmacovigilance system registered with EudraVigilance. We provide contractual partners whose drugs we market based on a distribution licence with the following pharmacovigilance services:

  • creation of RMP (risk management plan) during the drug registration process,
  • ensuring pharmacovigilance services for products distributed under licences where CZ Pharma is not the drug marketing authorisation holder,
  • continuous pharmacovigilance services after registration, creation of regular PSUR,
  • arranging the Public Scientific Service – VPOIS for products distributed under licences,
  • ensuring continuous service for Adverse reaction reporting of products distributed under licences and transmission to EudraVigilance using the BaseCon pharmacovigilance database,
  • services of a qualified person for pharmacovigilance.

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Storage And Distribution

CZ Pharma is an authorised distributor of human drugs and veterinary drugs and it has sufficient storage and subsequent distribution capacity in its own distribution warehouses. We provide our contractual partners with the following distribution services:

  • inspection of goods upon delivery from the producer, clearance of goods including Intrastat reporting,
  • storage of products (consignment) at a temperature maintained at 15–25 °C, storage in a cold chain at 2–8 °C,
  • storage of drugs containing narcotic and psychotropic substances in approved areas,
  • storage of veterinary drugs and medical devices,
  • customers' online access to inventory management, analyses of their goods sales, planning, online monitoring of storage conditions,
  • distribution of goods according to customer order by our own validated vehicles, including guarantee of a cold chain at 2–8 °C, online monitoring of temperature during transportation,
  • ensuring ordered recalls of goods from customers, collection of returned goods, disposal of defective goods,
  • supplies of drugs for clinical trials and distribution of drug samples,
  • services of a qualified person for distribution.

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Quality Control, Clinical Trials, Batch Release

  • import of drugs from non-EU countries, analytical testing of these released batches for the purposes of the marketing authorisation holder,
  • changes to secondary packaging (re-packaging), changes to drugs' patient information leaflets for the purposes of the marketing authorisation holder, re-release of batches,
  • ensuring of clinical trials, pharmacoeconomic and observation studies (upon request, third party),
  • ensuring of stage II and II pre-registration studies, and stage IV post-marketing studies (upon request, third party),
  • services of a person qualified for production (upon request).
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