In brief
The quality of a medicinal product does not end at the factory gate. On the way from the manufacturer via wholesale and storage to the pharmacy or hospital, it can suffer from wrong temperatures, humidity, damage or theft, and falsified medicines can enter the supply chain through unsecured routes. Good Distribution Practice (GDP) sets out how storage and transport must be carried out so that this does not happen.
Service providers in this area are pharmaceutical wholesalers, storage and logistics companies, and freight forwarders and couriers handling temperature-controlled goods. They take over storage, picking, dispatch and transport, often also for refrigerated goods and for investigational medicinal products in clinical trials.
When you need this
Hardly any manufacturer runs the entire distribution itself. Anyone placing a medicinal product on the market usually engages a warehouse that takes in the goods after release and delivers them to wholesalers, pharmacies or hospitals, and transport providers for the individual routes. The selection is particularly critical for products that must be stored refrigerated or frozen, and for deliveries to clinical trial sites, where small quantities must arrive on time and with a complete temperature record.
Legal basis and rules
Under Section 4(22) AMG, wholesale distribution is any professional or commercial activity for the purpose of trading that consists of procuring, holding, supplying or exporting medicinal products. Anyone engaged in it needs a wholesale distribution authorisation under Section 52a AMG. It is granted by the authority of the Land (federal state) in which the site is located and requires, among other things, suitable premises and a Responsible Person with the necessary expertise. A manufacturing or import authorisation includes wholesale distribution of the medicinal products it covers.
The purpose of trading is decisive. According to the interpretation of the Länder authorities, a pure storage or transport service provider that stores and ships medicinal products on behalf of a manufacturer or wholesaler, without owning them or trading in them itself, is not engaged in wholesale distribution and therefore does not need a wholesale distribution authorisation. It is, however, subject to supervision by the Land authority under Section 64 AMG and must notify its activity before starting under Section 67 AMG. As soon as it buys and resells medicinal products itself, it becomes a wholesaler and needs the authorisation.
Temperature control in the warehouse
Under the GDP Guidelines, a temperature mapping exercise must be carried out under representative conditions before a storage area is used. Its results determine where the monitoring devices are placed, especially in the areas with the greatest fluctuations. The mapping is repeated based on a risk assessment and whenever significant modifications are made to the premises or the temperature control equipment. For small premises at room temperature, a risk assessment, for example with regard to heaters, with appropriately placed monitors is sufficient.
Transport
The supplying wholesaler is responsible for ensuring that the temperature stays within an acceptable range during transport and that this can be demonstrated. Planning is based on a risk assessment of the delivery routes. Temperature monitoring equipment in vehicles and containers must be maintained and calibrated at regular intervals, at least once a year. If a temperature excursion or damage occurs, the distributor and the recipient must be informed, and there must be a procedure for investigating such excursions. Where cool packs are used in insulated boxes, the medicinal products must not come into direct contact with them, and staff must be trained in packing the boxes according to the season.
Suppliers, customers and service providers
Wholesalers may only obtain medicinal products from holders of a wholesale distribution or manufacturing authorisation and may only supply persons who themselves hold a wholesale distribution authorisation or are authorised to supply medicinal products to the public. Before entering into a new business relationship with a supplier, a due diligence check is required, which also looks out for unusual prices or large quantities of medicinal products that are otherwise in short supply. Anyone who outsources activities remains responsible under Chapter 7 of the Guidelines, audits the contract acceptor before starting and whenever there is a change, and must approve any subcontracting to third parties in advance.
How the collaboration works
What to look for when selecting a service provider
Frequently asked questions
Does a manufacturer need a wholesale distribution authorisation to distribute its own products? +
Does a logistics service provider need its own wholesale distribution authorisation? +
Who is liable for temperature excursions during transport? +
How often must a warehouse be re-mapped? +
Sources
Every statement in this text was checked against these primary sources (as of 10.11.2026). Laws, guidelines and authority websites, no advertising.
- Gesetze im Internet · __4.html
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- Gesetze im Internet · BJNR023700987.html
- EUR-Lex (EU-Recht) · TXT
- gesundheit.bremen.de · GUTE+VERTRIEBSPRAXIS+GDP+GUIDELINE.pdf
- gmp-compliance.org · distribution-of-temperature-sensitive-pharmaceuticals-requi…
- EU-Kommission (EudraLex) · eudralex-volume-4_en
- EU-Kommission (EudraLex) · 2015-10_annex15_0.pdf
- EU-Kommission (EudraLex) · reg_2016_161_en_0.pdf
- ZLG · index.php
- schleswig-holstein.de · 3005MerkblattArzneimittelgrosshandel.pdf
- Gesetze im Internet · __64.html
- Gesetze im Internet · __67.html