Life Sciences Bit: New draft law concerning the evolution of the drug circuit
Some changes to come in Luxembourg concerning importation, manufacturing and use of medicinal products and active substances.
Do you plan to import or manufacture medicinal products and active substances in Luxembourg? Here are some new conditions you need to keep an eye on, contained in the new draft law n°7383:
1. With regard to the import of medicinal products, it is planned that:
import of medicinal products shall be authorised by the Luxembourg Minister of Health;
the Division of Pharmacy and Medicines of the Directorate of Health will be responsible for matters relating to medicines and pharmaceutical products, in particular, manufacturing, advertising, distribution, import and export of these medicinal products.
2. With regard to the import of active substances for manufacturing of medicinal products in Luxembourg:
if your company is established in Luxembourg, the import of active substances shall be notified by means of a registration form to the Minister of Health;
the imported active substances shall be manufactured in accordance with standards of good manufacturing practice published by the European Commission;
the imported active substances shall be accompanied by a written confirmation of compliance from the competent authority of the exporting third country, certifying that: the manufacturing standards applicable to the entity manufacturing the exported active substance are at least equivalent to those published by the European Commission;
the manufacturing entity is subject to regular, strict and transparent controls and effective measures to implement good manufacturing practices, including repeated and unannounced inspections, ensuring at least equivalent protection of public health to that provided by the European Union;
in the event of a detection of non-compliance, the information shall be immediately communicated to the European Union by the exporting third country;
the importation of active substances is carried out under the supervision of a responsible pharmacist chosen by your company and approved by the Minister of Health. The responsible pharmacist may only provide supervision services to one importer:
the indications that the person wishing to import active substances must provide in the application for registration, the conditions under which the authorisation may be granted, the obligations of the importer and the responsible pharmacist, will be determined by a Grand-Ducal regulation.
Manufacturing and use requirement
1. With regard to the manufacturing of active substances in Luxembourg:
the manufacturers established in Luxembourg notify to the Minister of Health by way of a registration form of the manufacturing of the active substances.
2. With regard to the use of medicinal products in Luxembourg:
in imperative situations, a temporary authorisation for using a medicinal product may be granted, by the Minister of Health:
for occasional and nominative prescriptions of a medicinal product which has an authorisation for the Luxembourg market or abroad, but whose use for a specific indication or application is not included in its instructions;
for a compassionate use of a medicinal product which is either the subject of a pending marketing authorisation application or during clinical trials;
in order to use a medicinal product which does not have an authorisation for the Luxembourg market or abroad: for a specific application which is not included in its instructions, or in order to combat spread of pathogens, toxins, chemical agents or nuclear radiation.For more information, please do not hesitate to contact our dedicated team in Life Sciences at Loyens & Loeff.
For more information, please do not hesitate to contact our dedicated team in Life Sciences at Loyens & Loeff.
Emilia FronczakSenior Associate Attorney at law / Avocat à la Cour
Emilia Fronczak, senior associate, is a member of the Litigation & Risk Management Practice Group in our Luxembourg office. She focuses on dispute resolution and advises mainly on data protection, IP, employment and EU law.T: +352 466 230 E: firstname.lastname@example.org
Veronica AroutiunianSenior Associate Attorney at law / Avocat à la Cour
Veronica Aroutiunian, senior associate, is a member of the Investment Management Practice Group in our Luxembourg office. She focuses on fund structuring, notably private equity and hedge funds.T: +352 466 230 386 E: email@example.com