We focus on pharma & biotech
Genome Lawyers are uniquely well-connected, serving your business in a pragmatic and effective way.
Advice, litigation & regs-DD for global clients
Genome Lawyers has expertise in a wide range of issues relating to law and the pharma & biotech (human and veterinary) industry, such as:
Assistance and possible administrative law review as to administrative penalties (bestuurlijke boetes)
Issues on the interface between regulatory & IP
Interactions with the competent authorities, such as with the Inspectorate for Healthcare and Youth (IGJ), Medicines Evaluation Board (CBG-MEB), Central Committee Medical Research (CCMO), European Medicines Agency (EMA) and the RIVM
Biotech: ATMPs advice, demarcation
Advice regarding online pharmacies (see below)
Issues concerning clinical trials and clinical trial agreements
Transactional Regulatory Scan: assistance in, or prior to, M&A deals or investments as to regulatory law
Strategic advice, e.g. re compounding or collegial delivery
Reimbursement, pricing, negotiating financial arrangements, lobbying
Pharmaceutical adverting, complaints procedures
Functioning as an EU pharmaceutical law expert, e.g. in litigation
Preference policy bids assistance
As daily life becomes more intertwined with an online presence, the shift toward using digital platforms to purchase goods and services is growing. For patients looking to purchase medicinal products, ordering medicines online facilitates barrier-free access to medication and perhaps prescriptions. However, the danger of purchasing the wrong or falsified medication looms and threatens the possibly safety of patients. For that purpose, the following is relevant.
Common logo for online pharmacies
Within the EU, the legal framework of medicinal products for human use falls under the Medicines Directive. However, when the Medicines Directive came into application, the prevalence of using online pharmacies to purchase medicine was limited, if at all existent.
Since then, the Medicines Directive was amended to introduce the term ‘falsified medicinal product’, presenting a harmonised front to strengthen the framework of providing safe medication.
Online retailers of medicinal product are therefore required to be registered with the local competent authorities (for the Netherlands: see (https://www.aanbiedersmedicijnen.nl/). To denote that an online pharmacy is registered, specifications pertaining to the European logo which must be present on the website are detailed.
Tailored advice by Genome Lawyers
The founder of Genome Lawyers is an attorney-at-law focusing on pharma & biotech law, but has also previously been trained as a pharmacist, is holding a PhD in pharmacy and is an ex- Inspector for Healthcare and is therefore perfectly positioned to advise on this topic.
Genome Lawyers aims to provide tailored advice to its clients. First of all, some strategic advice may be required: are we setting up a new pharmacy, are we acquiring one or are we collaborating with a pharmacist with an established pharmacy. The status aparte of the so-called cross-border pharmacies in combination with common pharmacies is often underlined in such advice. As an expert in the rules on compounding, this topics may be explained as well.
Curious to know how Genome Lawyers can help you getting your pharmacy online?
Please do not hesitate to contact us.
Pharma and Biotech law specialists in Amsterdam
Genome Lawyers specialise in pharmaceutical and biotechnology law. Next to that, we assist medical devices companies. Based in Amsterdam, we serve clients across the globe. Our in-depth knowledge of the working practice of the regulatory bodies in the Netherlands, as well as across Europe, means we can provide rare insight and tailored advice. Our team is uniquely well-connected and committed to serving your business in a pragmatic and effective way.
With experience providing advice and litigation services for a wide range of global clients, we know how to deliver the solutions you need, so contact us today to arrange an initial consultation with our team.