H-1135 Budapest, Szabolcs utca 33.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

Mellékhatás bejelentő
Forgalmazói regisztráció

Fees

Type of consultancy

Fees

Scientific advice on new drug development

Pharmaceutical quality requirements

Interpretation of directives and quality guidelines for medicinal products

40 000 HUF + VAT

Pharmaceutical quality issues related to drug development

150 000 HUF + VAT

Assessment of ancillary medicinal substances incorporated in medical devices

450 000 HUF + VAT

Non-clinical development

Consultancy related to non-clinical development of medicinal products

150 000 HUF + VAT

Clinical development

Consultancy related to clinical development of medicinal products

150 000 HUF + VAT

Scientific advice on pharmacovigilance issues

Consultancy on pharmacovigilance issues related to new drug development

150 000 HUF + VAT

Interpretation of requirements and defining obligations in individual cases

40 000 HUF + VAT

Changing prescription status (OTC switch)

40 000 HUF + VAT

PASS, DUS, RMP, RMM etc.

Individual price offer

Quality assurance systems (GLP, GCP, GMP, GDP, GVP)

Authorization and inspection

50 000 HUF + VAT

Quality (assurance) systems

50 000 HUF + VAT

Consultancy related to manufacturing processes (GMP)

50 000 HUF + VAT

Consultancy related to drug distribution, wholesale trade of medicinal products (GDP)

50 000 HUF + VAT

Scientific advice related to applications for marketing authorisation

Legal basis of application

40 000 HUF + VAT

Brand name

40 000 HUF + VAT

Packaging, SPC and package leaflet

40 000 HUF + VAT

Marketing

40 000 HUF + VAT

Regulatory process, in general

40 000 HUF + VAT

Consultancy on drug quality discrepancies and failures

40 000 HUF + VAT

Consultancy on patient support programs

40 000 HUF + VAT

Consultancy on other medicinal products

Individual price offer

Consultancy on health-economical issues

Incidence, prevalence and the new technology’s relevance in terms of financing

450 000 HUF + VAT

Assessing comparators

40 000 HUF + VAT

Assessing existing evidence

40 000 HUF + VAT

Defining the type and timeframe of the analysis

40 000 HUF + VAT

Defining the relevant patient population(s)

40 000 HUF + VAT

Defining measures of health gain

40 000 HUF + VAT

Related costs

40 000 HUF + VAT

Evaluation of health-economical modelling and the effects on public financing

100 000 HUF + VAT

Consultancy onmedical devices

Requirements for qualifying for a medical device

40 000 HUF + VAT

Consultancy on trading and distribution (for authorised product)

40 000 HUF + VAT

Consultancy on registration of medical device

40 000 HUF + VAT

Consultancy on medical device software/app

40 000 HUF + VAT

Consultancy on clinical studies of medical devices

40 000 HUF + VAT

Consultancy on issues dedicated to the OGYÉI Department of District Pharmacists

Consultancy on the appropriateness of pharmacy-specific software

300 000 HUF + VAT

Assessing IT developments and e-health applications

300 000 HUF + VAT

Automated systems for effective drug supply

450 000 HUF + VAT

Assessing IT devices and software products related to specific clinical pharmacy activities

450 000 HUF + VAT

Scientific advice related to early-phase drug development

Scientific advice (consultation)

free

Regulatory advice

free

Face-to-face meeting (max. 90 mins- In addition to the advice fee)

60 000 HUF + VAT


Last updated: 2021.06.10 16:05