The Qualified Person (QP): The Critical Role in Pharmaceutical Licensing
Pharmaceutical wholesale distribution and importation require different responsible personnel. Wholesale distributors must appoint a Responsible Person (RP) who ensures compliance with Good Distribution Practice (GDP). Manufacturers and importers operating under a Manufacturing and Import Authorisation must appoint a Qualified Person (QP) responsible for GMP batch certification. Companies conducting both wholesale distribution and third-country importation must ensure that both sets of regulatory responsibilities are properly assigned. The QP is not simply a manager or a compliance officer: they are a designated specialist with specific educational and experiential qualifications who bears personal legal responsibility for certifying that each batch of medicinal products meets the applicable quality standards before release.
QP qualifications — what is required
Under EU Directive 2001/83/EC Article 49, a Qualified Person must hold a diploma in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology from a recognised university or equivalent institution. In addition, the QP must have at least two years of practical experience in one or more authorised undertakings in the fields of quality control, production, or release of medicinal products. The combination of academic qualification and practical experience is non-negotiable — neither alone is sufficient.
What the QP certifies
For each batch of medicinal products that the licensed company releases for distribution or sale, the QP must certify that: the batch has been manufactured and controlled in accordance with the requirements of its marketing authorisation and applicable GMP/GDP standards; the batch has been tested in accordance with the testing requirements; and all relevant EU requirements have been complied with. The QP signs the batch release documentation personally and is personally accountable for each batch they certify. This personal accountability means that the QP must have genuine access to the batch records and quality data — a nominal QP appointment without real involvement in the release process does not satisfy the regulatory requirement.
QP for wholesale distribution vs. manufacturing
Wholesale distribution and pharmaceutical manufacturing or importation involve different statutory responsibilities. A Wholesale Distribution Authorisation holder must designate a Responsible Person (RP) who oversees compliance with GDP, including storage, transportation, supplier verification, traceability and recall procedures. The RP does not perform statutory GMP batch certification merely because medicines are received or stored.
A Manufacturing and Import Authorisation holder must designate a Qualified Person (QP) responsible for certifying medicinal product batches before their release to the EU market, in accordance with Article 51 of Directive 2001/83/EC and the applicable GMP requirements. Imported batches may be subject to EU batch testing requirements, taking into account relevant exemptions and international agreements. For manufacturing, the QP certifies the entire manufacturing process and is directly involved in production quality control.
Finding a qualified QP in Lithuania
Qualified Persons who are willing to serve as the named QP for a pharmaceutical licence are not universally available — particularly for smaller distributors that cannot offer full-time employment. The QP may be employed part-time, contracted as a consultant, or outsourced through a specialist pharmaceutical services provider. The VVKT accepts QP arrangements where the QP is not a full-time employee, provided the QP has genuine access to the company’s quality systems and is available when needed to review and release batches. We advise on QP sourcing and structure the QP arrangement correctly for each licensing engagement.
QP outsourcing — is it permitted?
Yes — the VVKT accepts outsourced QP arrangements provided the arrangement is documented in a written agreement that defines the QP’s scope of responsibility, access rights, and obligations. The agreement must be available for VVKT inspection. The QP must be reachable and available whenever batch release decisions are required. Outsourced QP arrangements are common among smaller pharmaceutical distributors and importers who do not have sufficient volume to justify a full-time in-house QP. We advise on the structure of QP outsourcing agreements and can introduce VVKT-registered QPs through our specialist network.
Good Distribution Practice (GDP): What VVKT Inspects
Good Distribution Practice is the quality framework that governs the wholesale distribution of medicinal products in the EU. It is set out in the EU GDP Guidelines (2013/C 343/01) and is the standard against which VVKT inspectors assess wholesale distribution premises before issuing and renewing the authorisation. Understanding what the inspection looks for — and preparing the premises accordingly — is the most effective way to achieve first-time authorisation.
Quality management system
The GDP quality management system (QMS) is the documented framework that defines how the company manages pharmaceutical distribution quality. It must include: a quality manual describing the overall quality framework; standard operating procedures (SOPs) for all key activities (goods receipt, storage, picking and packing, dispatch, returns, recalls, and customer complaints); a system for managing deviations and corrective and preventive actions (CAPAs); a qualification and training programme for all relevant staff; and a procedure for self-inspection. The QMS must be operational — not merely documented — at the time of inspection.
Premises and equipment
The warehouse premises must provide: appropriate temperature and humidity conditions for all stored products (typically ambient 15–25°C; cold chain 2–8°C for products requiring refrigeration); a separate quarantine area where products of uncertain status are held pending release or rejection; segregated storage for returned goods, rejected goods, and suspect or falsified medicines; and a goods receipt area where incoming deliveries can be checked before being accepted into stock. Temperature mapping of the storage areas must be conducted before the first inspection and repeated after any significant changes to the premises or equipment. Temperature monitoring must be continuous — validated monitoring systems are required for cold chain storage.
Supplier and customer verification
Before receiving medicines from a supplier or selling to a customer, the wholesale distributor must verify that the other party is authorised. For suppliers, this means confirming that the supplier holds a valid manufacturing authorisation, marketing authorisation, or wholesale distribution authorisation as applicable. For customers, this means confirming that the pharmacy, hospital, or distributor is authorised to receive medicines. The VVKT maintains a public database of authorised wholesale distributors and pharmacies — we advise on the verification procedure and document it in the company’s SOPs.
Falsified medicines — track and trace
EU Directive 2011/62/EU (the Falsified Medicines Directive) and Delegated Regulation (EU) 2016/161 require that prescription medicines carry a unique identifier (2D barcode) and a tamper-evident device, and that these identifiers are verified and decommissioned at the point of dispensing. Wholesale distributors must have systems to check the authenticity of medicines they receive and dispatch, and to report suspect falsified medicines to the VVKT. Compliance with the falsified medicines framework is assessed during GDP inspections.
The Pharmaceutical Licence Application Process
The VVKT application process for pharmaceutical authorisations is more substantive than most other licensing applications in Lithuania — it involves documented quality systems, a named QP, and a pre-authorisation inspection. We manage the complete process.
1
Authorisation type assessment
We confirm the correct authorisation type for the intended pharmaceutical activity — wholesale distribution, pharmacy operation, import, or a combination. For companies that plan to both import and distribute, the relationship between the two authorisations is clarified at this stage. We also assess whether any products the company intends to handle are classified as medicinal products and therefore within scope.
2
QP identification and engagement
We identify a suitable Qualified Person for the licence — either from the client’s existing team (if a qualifying individual is already employed) or through our specialist pharmaceutical network. The QP’s qualifications and experience are verified against the EU Directive 2001/83/EC requirements. The QP arrangement is documented in a written agreement before it is submitted to VVKT.
3
Premises assessment and GDP gap analysis
We assess the intended premises against GDP requirements — identifying gaps in temperature control, quarantine segregation, monitoring systems, and storage capacity before the VVKT inspection. A GDP gap analysis report identifies what must be remediated before the application is submitted. This step prevents first-time inspection failures.
4
Quality management system preparation
We advise on the key SOPs and quality documents the VVKT will expect to see at inspection. For new companies, we prepare a GDP quality manual and core SOPs covering goods receipt, storage, dispatch, returns, recalls, and self-inspection. For companies with existing systems, we review and update documentation to align with Lithuanian and EU GDP requirements.
5
Document preparation and application submission
We prepare the complete VVKT application package: completed application forms, company registration extract, QP documentation (CV, qualifications, designation agreement), premises details and floor plan, equipment list, GDP quality manual summary, and personnel qualifications summary. The application is submitted electronically through the VVKT’s e-services portal.
6
VVKT review and query response
The VVKT reviews the application documentation and may raise questions before scheduling the inspection — particularly about the QP’s qualifications or the premises’ compliance with GDP standards. We manage all VVKT correspondence and prepare written responses to any queries promptly.
7
Pre-authorisation inspection
VVKT inspectors conduct an on-site inspection of the premises. Inspectors assess the physical premises, review the quality management system documentation, interview the QP and responsible staff, and test key procedures. We prepare the client for the inspection — conducting a mock walkthrough, briefing the QP and relevant staff, and ensuring all documentation is organised for inspector review.
8
Authorisation issued
Following a satisfactory inspection, the VVKT issues the pharmaceutical authorisation. Following a satisfactory regulatory assessment and any required inspection, VVKT issues the applicable pharmaceutical authorisation. Lithuanian pharmaceutical activity licences are generally issued without a fixed five-year validity period. Licence holders must maintain compliance with the relevant legal requirements and notify VVKT of changes requiring regulatory approval or amendment, including changes to authorised activities, premises and designated responsible personnel. Wholesale distributors must maintain an appropriately qualified Responsible Person (RP), while manufacturers and importers must maintain a Qualified Person (QP). We advise on post-authorisation change notification requirements.
Controlled Substances: Additional Requirements
Pharmaceutical companies handling controlled substances — narcotics, psychotropic substances, and their precursors — face additional regulatory requirements beyond the standard pharmaceutical authorisation framework. These requirements apply under the Law on the Control of Narcotic and Psychotropic Substances and Under Law on Precursors of Drugs and Psychotropic Substances.
What requires a controlled substances licence
Any company that manufactures, imports, exports, distributes, stores, or uses controlled substances — including Schedule I–IV narcotics and psychotropic substances as classified under Lithuanian law — requires a separate controlled substances licence from the VVKT. This applies to wholesale distributors who handle prescription painkillers (opioids), anxiolytics, hypnotics, and other controlled medicines, as well as to pharmacies that dispense such medicines. The controlled substances licence is additional to and separate from the standard wholesale distribution authorisation or pharmacy licence.
Additional requirements for controlled substances
- Secure, separately locked storage — controlled substances must be stored in a dedicated, locked area with restricted access and an access control log
- Transaction records — every movement of controlled substances (receipt, dispatch, dispensing, return, and destruction) must be recorded in a dedicated register maintained separately from standard stock records
- Quarterly reporting to VVKT — companies must report controlled substance movements to the VVKT quarterly
- Annual stock reconciliation — an annual physical count of controlled substances must be conducted and reconciled to the transaction records
- Staff access controls — only specifically authorised staff may have access to the controlled substances storage area
- Destruction protocol — expired or returned controlled substances must be destroyed in the presence of a VVKT representative using a documented protocol
Precursors — a separate category
Drug precursors — chemical substances that can be used in the illicit manufacture of controlled drugs — are regulated separately from controlled medicines under EU Regulation 273/2004 and 111/2005. Companies that handle Category 1 precursors (such as ephedrine and certain acetates) must be licensed by the VVKT under the precursor control framework, independent of any pharmaceutical licence they may hold. We advise on precursor licensing alongside pharmaceutical licensing for companies whose products or raw materials fall within the precursor categories.
Pharmaceutical Authorisations: At a Glance
Pharmaceutical Licence Service Pricing
Pharmaceutical licensing is a substantive engagement — the QP identification, GDP gap analysis, quality system documentation, and inspection preparation are each specialist workstreams in their own right. We quote per engagement after an initial assessment call. The indicative service fees below reflect typical engagements; complex or multi-site authorisations are quoted individually.
VVKT state fees
The VVKT charges state application fees for pharmaceutical authorisations. Current fees are published on the VVKT website and are subject to change. For wholesale distribution authorisations, the fee is typically in the range of €300–€500. For pharmacy licences, fees vary. We confirm the current state fee at the time of each engagement and include it in the total cost estimate. State fees are payable to the VVKT directly and are separate from our service fees.
Frequently Asked Questions
