H-1051 Budapest, Zrínyi u. 3.

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

Mail: 1372 P.O. Box: 450.

MAGYAR

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