Home / People / Miriam Fuchs
Miriam Fuchs

Miriam Fuchs

Senior Associate

CMS Cameron McKenna Nabarro Olswang LLP Magyarországi Fióktelepe
YBL Palace
Károlyi utca 12
1053 Budapest
Hungary
Languages Hungarian, English

Miriam is a senior associate in the life sciences and commercial teams at CMS Budapest. She is a life sciences specialist who is regularly involved in commercial matters as well.

Miriam has been involved in various pharmaceutical matters mainly involving simple to complex regulatory issues. These issues concern over-the-counter medicines, prescription only medicines, medical aids, cosmetics, medical devices and food supplements. Miriam has extensive experience of providing legal advice on clinical trials, categorization of medical devices and reimbursement of medical aids and medicinal products. She frequently advices her clients in relation to compliance with local laws and codes of conduct and thus, she regularly provides trainings to her clients.

In addition to the above, Miriam provides commercial advice to her clients on a daily basis. She also has experience in representing clients in product liability, product recall cases and proceedings before regulatory bodies and authorities, such as e.g. the National Institute of Pharmacy and Nutrition.

Miriam is recommended by Chambers & Partners in the area of Lifesciences. 

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"Her advice is very comprehensive and business-oriented".

Chambers, 2020

"She was always available when I needed her, her knowledge of the legal subject is very high and she is very client-oriented".

Chambers, 2020

"She has an excellent attitude. She is very responsive, provides excellent support and always makes you feel secure," adding: "As a client, you know you are being taken care of."

Chambers, 2018

Relevant experience

  • Representing some of our clients before the National Health Insurance Fund (NEAK) in relation to tender proceedings concerning active substances subject to itemized financing; providing ongoing regulatory and public procurement law advice to the clients in relation to the NEAK tenders.
  • Cord Blood in relation to the licensing procedure of the client’s operation, drafting agreements related to the stem cell bank. 
  • GE on evaluation of donation practice and preparing related documents. Assisting the client on the drafting of commercial agreements.  
  • A major pharmaceutical company on genetic testing and biobanking activity in Hungary.
  • Roche on the regulations on clinical trials of medicinal products; drafting various clinical trial agreements; providing legal advice on the classification of its medical devices. advising the company on its donation and promotional activity; providing legal advice on the distribution, marketing and labelling issues of its IVD products.
  • A pharma company on the revision of their template agreements to be concluded with health care professionals and health care organizations; providing legal advice on the reimbursement of medicinal products under and the price volume agreements with the National Health Insurance Fund and on the conditions of the transparency obligation set forth in the AIPM's Code of Ethics.
  • Companies in non-interventional clinical trials in Hungary.
  • J&J on several product liability cases, including liability cases of medicinal products, medical devices and cosmetic products. Assisting those clients in the communication with the patients / consumers and the negotiation process. 
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Education

  • 2011 - Doctor of Law, Eötvös Loránd University
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Memberships

  • Budapest Bar Association, 2015
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07 May 2021
Leg­al cur­rent is­sues re­lated to drug pro­mo­tion prac­tice, an over­view of...
Dur­ing this we­bin­ar we will dis­cuss top­ics in­clud­ing ba­sic con­cepts, leg­al back­ground, con­tracts, presents, dona­tions, samples, bro­chures, pro­mo­tion­al ma­ter­i­als, hos­pit­al­ity and sup­port Re­gis­tra­tion...
15 January 2021
Hun­gari­an phar­ma­ceut­ic­al au­thor­ity ordered to con­duct new pro­ceed­ing against...
After a ju­di­cial su­per­vi­sion pro­ced­ure found flaws in an in­vest­ig­a­tion by the Hun­gari­an phar­ma­ceut­ic­al au­thor­ity (OGYÉI), the Bud­apest Cap­it­al Re­gion­al Court ordered the OGYÉI to con­duct a new pro­ceed­ing...
14 December 2020
CMS Ex­pert Guide to di­git­al health apps and telemedi­cine
Fu­ture fa­cing Di­git­isa­tion is ad­van­cing stead­ily. Its pi­on­eer­ing in­nov­a­tions chal­lenge all parties in­volved. One of the most im­port­ant as­pects in this area is the huge po­ten­tial that lies in the di­git­isa­tion...
Comparable
09 December 2020
CMS Ex­pert Guide to vac­cine com­pens­a­tion re­gimes in the CEE
Vac­cine com­pens­a­tion re­gimes in them­selves are com­plex and con­stantly chan­ging. Couple this with a glob­al pan­dem­ic and you have an un­cer­tain and hard to nav­ig­ate pic­ture. Many phar­ma­ceut­ic­al com­pan­ies...
Comparable
19 June 2020
Hun­gary is­sues new tem­por­ary rules for the prac­tice of telemedi­cine
As a res­ult of the coronavir­us pan­dem­ic, the is­sue of telemedi­cine has be­come a pri­or­ity in many coun­tries, in­clud­ing Hun­gary, which has ex­pan­ded the per­miss­ible scope of the doc­tor-pa­tient re­la­tion­ship...
20 April 2020
CMS Ex­pert Guide to ad­vert­ising of medi­cines and med­ic­al devices
Ad­vert­ising of phar­ma­ceut­ic­als and med­ic­al devices is a chal­len­ging area for the Life Sci­ences and Health­care in­dustry.The leg­al frame­work is con­stantly chan­ging. Due to very few laws on this area, there...
20 April 2020
CMS Ex­pert Guide to can­nabis law and le­gis­la­tion
In re­cent years can­nabis trade and re­lated activ­ity has de­veloped in­to a growth busi­ness area. In the life sci­ences and health­care fields there have been in­creases in the num­bers of pa­tients hav­ing ac­cess...
20 April 2020
The Hun­gari­an phar­ma­ceut­ic­al au­thor­ity closed an­oth­er pro­mo­tion­al in­vest­ig­a­tion...
The Hun­gari­an phar­ma­ceut­ic­al au­thor­ity (OGYÉI) pub­lished a new de­cision on its pro­mo­tion­al in­vest­ig­a­tion car­ried out against a phar­ma­ceut­ic­al com­pany, in which the au­thor­ity es­tab­lished sev­er­al in­fringe­ments...
16 April 2020
Hun­gary: Tem­por­ary meas­ures re­lat­ing to the sup­ply and use of medi­cin­al...
New Hun­gari­an Gov­ern­ment De­crees in­tro­duced tem­por­ary meas­ures re­lat­ing to the sup­ply and use of medi­cin­al products dur­ing the state of emer­gency ordered in re­sponse to the COV­ID-19 pan­dem­ic. These meas­ures...
20 December 2019
Hun­gary's health au­thor­ity pub­lishes draft guid­ance on pro­mo­tions
On 12 Septem­ber 2019, the Hun­gari­an Na­tion­al In­sti­tute of Health and Phar­ma­ceut­ic­als (OGYÉI) pub­lished its draft guid­ance on the rules reg­u­lat­ing the pro­mo­tion­al activ­it­ies of phar­ma­ceut­ic­al com­pan­ies. ...
19 June 2019
Hun­gary's health in­sti­tute passes res­ol­u­tions on pa­tient sup­port pro­grammes
In late May, the Hun­gari­an Na­tion­al In­sti­tute of Health and Phar­ma­ceut­ic­als (OGYÉI) pub­lished res­ol­u­tions on pa­tient sup­port pro­grammes. In Hun­gary, it is not ob­lig­at­ory to provide pre-no­ti­fic­a­tion...
05 April 2018
Gov­ern­ment's Plans on the De­vel­op­ment of Med­ic­al Tech­no­logy In­dustry
In Res­ol­u­tion No. 2123/2017 (XII. 29.), the Hun­gari­an Gov­ern­ment an­nounced its plans for the de­vel­op­ment of med­ic­al tech­no­logy in­dustry. The Gov­ern­ment is­sued of­fi­cial re­quests to the fol­low­ing min­is­tries:...