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 |
