How to open a pharmaceutical or medical device factory in Moldova: pharmaceutical preparations, active substances and basic pharmaceutical products, and medical and dental devices

How big the market is

For 2025, 29 companies in the pharmaceutical industry filed financial statements, with 795 employees and sales revenue of 1.1 billion lei. A year earlier there were 31. Of the 29, 16 have fewer than ten employees.

The average gross wage in the fourth quarter of 2025 was 27,261 lei, almost double the manufacturing average of 14,025 lei. The economy-wide average for the same quarter was 16,355 lei. There are no separate figures for medical devices: class 32.50 is counted together with jewellery, toys, sports goods and brushes.

What permits apply

Medicines may only be manufactured under a licence. The law on pharmaceutical activity puts the production of medicines and medicinal substances under the same licence as a pharmacy, issued by the Medicines and Medical Devices Agency for five years. Besides the licence, the factory needs the manufacturing and import authorisation and the good manufacturing practice certificate. Only then does each medicine receive its own marketing authorisation.

Medical devices follow a different regime. They need no licence and no sanitary operating authorisation: they are notified to or registered with the same agency. Pharmacies and pharmaceutical warehouses, which handle medicines once they have been made, have a page of their own, on health, private clinics and pharmacies.

The manufacturing authorisation and good manufacturing practice

The manufacturing authorisation is required for each manufacturing site, each pharmaceutical form and each operation, including division into smaller packs and packaging. It is required even when everything you make goes for export. The application is filed by a company registered in Moldova, with the list of medicines, a description of the premises, equipment and processes, the site master file, and the contracts with the qualified person and key staff. The agency’s inspectors check the site, and the decision comes within 90 days of the complete file. The authorisation is issued free of charge and with no expiry.

The rules of good manufacturing practice are those of the European directive, transposed by a Government decision in 2026. The factory must have a pharmaceutical quality system, trained staff, job descriptions and an organisation chart. It may use only active substances manufactured and distributed under good practice and audits its suppliers. The GMP certificate is issued after an inspection, in Romanian and English, for three years.

The qualified person

Without a qualified person, no manufacturing authorisation is issued. This is the specialist who certifies that each batch has been manufactured and checked in line with the medicine’s marketing authorisation. They must hold an integrated higher degree in pharmacy, recognised in Moldova, and have at least two years’ experience at a company authorised to manufacture medicines. They must be permanently available, not only during inspections.

For a new company, the qualified person is usually the first person you look for, before the premises. If the owner meets the requirements, they can take on the role themselves.

Putting a medicine on the market, and its price

A medicine may be sold in Moldova only with a marketing authorisation. Under the general procedure, authorisation takes up to 210 days from the filing of a valid application and payment of the fee. For medicines already approved by the European Medicines Agency or by European Union member states there is an accelerated procedure that takes up to ten working days. The first authorisation is issued for five years, and after renewal it has no expiry. Its holder pays an annual monitoring fee, based on the number of pharmaceutical forms.

The manufacturer’s price is approved by the agency and entered in the National Catalogue of Manufacturer Prices. The markup that can be added on top is capped and falls as the price rises. On a medicine costing up to 30 lei, the distributor and the pharmacy together may add at most 40%, and on one costing over 240 lei, at most 16%. The factory can sell directly to pharmacies, because the manufacturing authorisation also covers wholesale distribution of its own medicines.

Medical devices: notification or registration

Anyone who manufactures, imports, sells or repairs medical devices must employ at least one specialist in the field or a bioengineer. The rest depends on the CE mark. Devices with the CE mark are notified to the agency at least ten working days before they reach the market, with the declaration of conformity and the CE certificate, and the agency enters them in the State Register of Medical Devices. If it does not respond within ten working days, the devices are deemed to have been entered.

Devices without the CE mark go through conformity assessment and are registered before they are sold. Registration is completed within 30 days and is valid for five years, and a Moldovan manufacturer pays no registration fees. One exception matters for dental laboratories: dentures and other devices custom-made for a patient can be put into service without the CE mark, with the manufacturer’s declaration of conformity.

The environment: when a permit is required

The industrial emissions law covers medicines manufacturing at two levels. Manufacturing 500 kg or more of pharmaceutical preparations a day requires an environmental permit, which costs 20,000 lei and is issued for six years. Manufacturing pharmaceutical products on an industrial scale by chemical synthesis, fermentation or extraction, including intermediates, requires an integrated environmental permit, which costs 30,000 lei and is issued for 12 years.

Factories that use more than 50 tonnes of organic solvents a year must also meet the law’s emission limit values and report to the Environment Agency every year.

Which legal form to choose

For a medicines or medical device factory, the usual form is an SRL, which pays 12% income tax and whose liability is limited to the company’s own assets. The law on pharmaceutical activity guarantees the same conditions to state, private and mixed enterprises and provides that the state encourages pharmaceutical enterprises with foreign capital.

We handle the choice of CAEM codes, the articles of association, the filing with the Public Services Agency and the opening of the bank account. We prepare the application for the licence for pharmaceutical activity and the export paperwork, and for a foreign company we register a Moldovan company or a free economic zone resident. We can take over the accounting from the first month. What each service includes is on the corporate services page.