The legislation governing medicinal products and medical devices is extensive and complex. The core of our legal services is our knowledge of all aspects of product and company life cycles, and our vast industry knowledge.
International Trade, Regulatory and Government Affairs
At Muhoozi & Co. Advocates, we have a special focus on the life sciences industry with lawyers with complementary professional expertise who can advise on all essential issues relating to medicinal products, medical devices as well as food and feed. We work across borders, and thanks to our global network we are able to provide expert legal advice.
The legislation governing medicinal products and medical devices is extensive and complex. The core of our legal services is our knowledge of all aspects of product and company life cycles, and our vast industry knowledge enables us to advise all types of companies.
The process of obtaining a licence to sell medicinal and other products can be prolonged and difficult and require extensive data. We have in-depth knowledge of the legislation in this area, and we advise on all legal issues arising in connection with data protection, access to public administration files, etc. We also have broad experience of negotiating with government agencies and other public authorities and of how to handle regulatory issues relating to medical devices.
We advise on the special issues relating to the marketing and advertising of medicinal products and medical devices. We have vast experience of ensuring that the material and marketing efforts of companies comply with the statutory requirements and guidelines for this industry.
We have vast experience in relation to the regulatory framework for research and development as well as clinical trials, and we have insight into and knowledge of the types of documents required and can assist in their drafting.
Intellectual property rights
There are few other industries where intellectual property rights play such an important role. We know how important it is for a company to obtain and protect its intellectual property rights, and we appreciate the importance of protecting the company's exclusive rights. We also have special experience of litigating disputes involving intellectual property rights.
We advise on and tailor compliance programmes and emergency preparedness procedures to the needs of companies working with medicinal products and medical devices. We understand the needs of the industry and the special risks to which companies are exposed.
We offer advice on all aspects of product liability, e.g. in connection with product liability disputes, and we help draft limitation of liability clauses and warnings.
Corporate/M&A
Muhoozi & Co. Advocates's M&A team is among the most experienced teams in Uganda. We have extensive experience of how to handle the special issues relating to the sale and purchase of pharmaceutical companies and companies selling medical devices.
Competition law
Our competition law team has extensive experience of advising companies in this industry. Often, the markets involved are concentrated, which increases the risk of problems relating to competition law. Our expertise covers all areas relating to competition law, including merger control, anti-competitive agreements, abuse of dominant position as well as state aid and problems at the intersection between IPR and competition law.
Public procurement law
Public procurement legislation plays an essential role for companies selling medicinal products or medical devices. Medical devices, in particular, are mostly sold to public-sector customers, which are required to comply with the public procurement rules. We have extensive experience of advising companies during the tendering process and representing them in connection with complaints.
Dispute resolution
We are top ranked in the area of dispute resolution, including arbitration and mediation. On several occasions, our life sciences team has represented clients before the Ugandan courts, including the Supreme Court and the European Court of Justice.
Food and feed
The legislation governing food is intense and constantly changing. Our life sciences team has the necessary expertise and experience to advise companies on all aspects of food law, including research, compliance of manufacturers and distributors, import/export and marketing.
The food industry is highly regulated by EU law, but Uganda has special rules in several areas. We have vast experience of handling the uncertainty this may cause, and we are in dialogue with the public authorities on the problems faced by companies.
The composition of our specialist team also enables us to advise companies on all derivative problems, e.g. product liability, tax and IPR. Our lawyers are among the best in the areas of litigation and arbitration, and we have vast experience of representing our clients in cases not only before the Ugandan courts but also before international courts and institutions, including the European Court of Justice and the European Commission.
In recent years, food manufacturing companies have increasingly been allowed to market their products by means of health claims. We advise both Ugandan and foreign clients on all aspects relating to the packaging, labelling and marketing of products, including sale and marketing on the Internet.
The requirements for food ingredients are heavily regulated, and this area is characterised by a large number of special rules, including restrictions which are applicable only in Uganda. We advise Ugandan and foreign clients on the use of additives, nutrients, GMO products, novel food, animal ingredients and plant components and on other restrictions for ingredients, such as processing and chemical contaminants, e.g. pesticide residues.
We help companies establish self-monitoring programmes and advise them on how to handle health inspections. We have vast experience of dealing with improvement notices, prohibition orders and complaints. If sanctions are imposed by public authorities, we can help companies ensure that the sanction imposed is the least intrusive. We always keep in mind that non-compliance may result in substantial financial losses and damage to the company's reputation. For that reason, the dialogue with the public authorities is paramount to dealing with the challenges faced by our clients.
The food industry produces a large number of niche products. Our life sciences team advises on the sale and marketing of dietary supplements and products for special target groups, e.g. food for special medicinal purposes and sports nutrition products.
