The pharmaceutical field requires specialized advice, combining general legal provisions with legal regulations specific to the medical field. Our team has experience in handling cases in various areas related to the pharmaceutical field. We can offer you services such as
Advice on the interpretation and application of specific provisions and regulations.
As the pharmaceutical sector is subject to an increasingly complex regulatory framework, we offer expert advice on the interpretation and application of legal texts.
Whether we are talking about the regulatory aspects of the pharmaceutical industry, tax law, or competition law, the legislative framework is increasingly broad and subject to constant changes to keep pace with social needs and scientific progress. For this reason, its interpretation and application require an interdisciplinary approach.
Our team helps pharmaceutical specialists, manufacturers, or distributors of medicines and medical devices to keep up with the legislation affecting their business.
Assisting in control procedures carried out by the National Health Insurance House.
Our team of lawyers specializing in pharmaceutical law offers you support in your dealings with National and Territorial Health Insurance Companies.
Suppose you are a distributor of pharmaceutical products in contractual relations with the National House or the Territorial Health Insurance Houses. In that case, you will likely have to deal with a control activity from their specialized structures.
In this context, our team has the experience to assist you in communicating with the Houses and preparing the necessary control documents.
Assisting in the drafting of proposals for legislative changes in the pharmaceutical field.
We translate the wishes of pharmaceutical specialists into proposals for amendments to the legal texts to improve the legal framework.
According to Article 7 of Law No 52/2003 on transparency in decision-making in public administration, the initiating authorities of a draft document concerning regulatory acts shall submit it to public consultation at the same time as the preliminary inter-institutional consultation. Once submitted for public consultation, the possibility is opened for citizens to submit proposals, suggestions, and opinions on the draft legislative act.
In this context, taking into account the wishes but also the expected results of the people directly affected by the draft legislation, we will present our legal perspective for the elaboration of proposals for amendments to increase the chances that they will materialize into ideas that will form the substance of the regulation.
Obtaining authorization to sell pharmaceutical products.
We make it easy for you to ensure the legality of the sale of pharmaceutical products by obtaining the necessary authorizations.
Whether the discussion concerns the authorization of an institution to operate as a distributor of pharmaceutical products, the authorization to sell a new medicine, or the authorization required for the sale of certain types of drugs, obtaining them involves several procedures that need to be followed.
Whatever the situation, our team specializing in pharmaceutical law will draw up the necessary documentation and take all steps to ensure that your company sells pharmaceutical products following the legislation in force.
Assisting in negotiations for the conclusion of contracts for the intermediation and distribution of pharmaceutical products.
We help you negotiate contracts for the intermediation and distribution of pharmaceutical products so that your interests as a professional are best represented in the relationship with contractual partners.
During the negotiation period, before the actual conclusion of the contract, the persons present their mutual interests to each other promptly. This stage is critical as it is here that the parties can determine the desired effects of the act to be concluded. Also, how negotiations are conducted can be a valuable mechanism for interpreting the contract.
Drafting specific agreements for the distribution of pharmaceutical products.
Any activity relating to the distribution of medicines delegated to another person or entity must be carried out per the contract terms.
According to the regulations, the pharmaceutical industry must apply an advanced quality assurance system and achieve its pharmaceutical quality objectives by complying with the Guidelines on Good Manufacturing Practice for Medicinal Products for subsequent marketing authorization of medicinal products for human use.
That is why even contracts for the distribution of pharmaceutical products must be drafted in compliance with all legal rules in the field, and the Blaj Law team has the experience to help you meet all the required standards.