Reporting obligations
Within the scope of Section 52b sub-section 3c Medicinal Products Act, BfArM is obliged to create lists for supply-relevant and supply-critical active substances. The Advisory Council for shortages and supply disruptions of human medicines participates in the creation of the lists as appointed in the Medicinal Products Act. In addition, according to section 52b sub-section 3f AMG, BfArM in consultation of the Advisory Council, creates a list of finished medicinal products for which regular data transmission is considered necessary to adequately assess the supply situation.
The lists represent the basis for the voluntary commitment to report shortages defined in the Pharma Dialogue in 2016.
The Federal Institute for Drugs and Medical Devices (BfArM) provides an overview of current supply shortages for human medicinal products (excluding vaccines) in Germany, see Lieferengpass Datenbank (in German). These shortages are reported by the pharmaceutical companies and are based on their voluntary commitment to report supply shortages for supply-relevant medicinal products as declared in the German “Pharmaceutical Dialogue of the Federal Government”.
A shortage notification is considered particularly necessary if the number of marketing authorisation holders, manufacturers responsible for batch release or manufacturers of a specific active substance falls below a critical threshold. Additionally, the voluntary commitment to report supply shortages applies to all active substances for which a supply disruption already occurred in the past and for active subtances mentioned in the list of products excluded from substitution.
Affected active substances are summarized in the list of supply-crictial substances.
Additionally and not cited in the list of supply-critical substances, the voluntary commitment to report shortages applies also to products
- with a market share of 25 % and more and
- for products underlying the reporting obligation to hospitals according to Section 52b Sub-section 3a of the Medicinal Products Act.
A shortage is herein defined as an interruption of deliveries in the usual scope that is expected to last longer than 2 weeks or a significantly increased demand that cannot be met adequately.
Beside the described voluntary commtiment to report shortages there is an obligation to regularly report data on production, demand and stocks for certain products. This obligation is based on section 52b sub-section 3f AMG and was implemented as a possibilty to prospectively assess potential deficits and potential deficits or problematic situations regarding finished medicinal products considered critical.
Further details on reporting obligations, the technical aspects of data transmission and the corresponding lists can be obtained below.
List of supply relevant substances
List of supply critical substances
Regular reporting of data according to section 52b sub-section 3f AMG
In Section 52b of the German Medicinal Products Act (AMG) that deals with the supply of medicinal products, sub-section 3f specifies the regular reporting of data to assess the supply situation. This regular data transmission according to Section 52b sub-section 3f AMG is supervised on the operational level by the competent federal higher authority, the Federal Institute for Drugs and Medical Devices (BfArM), in agreement with the Paul-Ehrlich-Institut (PEI).
The Advisory Council for Supply Shortages has also been involved according to Section 52b sub-section 3b AMG in specifying the corresponding criteria. In its 2nd meeting on 21 October 2020, the Advisory Board defined the criteria for finished medicinal products which should be covered by regular data reporting. These criteria include
- finished medicinal products for which a supply disruption (Versorgungsmangel) has already been determined by the Federal Ministry of Health (BMG) in the past, as well as
- marketable medicinal products with a supply-relevant active ingredient and only one known marketing authorisation holder, active ingredient manufacturer or batch release manufacturer.
A corresponding list with the finished medicinal products that are subject to regular data transmission in accordance with Section 52b sub-section 3f AMG and their criteria is published in German on the BfArM website.
The BfArM has commissioned a service provider for the technical aspects of implementing and processing of the regular data transmission. The provided “Secure File Transfer Protocol” servers are being used by the companies to upload their data in a standardised format, specified by the BfArM and complying with data security and confidentiality. The service provider only processes the data and has no rights on the data. The data transmitted includes information on planned production, current stocks, as well as sales. The reporting of data regarding international stocks and sales is optional.
In addition, and in accordance with Section 52b sub-section 3f AMG, pharmaceutical wholesalers take part in the data transmission system as well by submitting data agreed with the BfArM on a weekly basis.
If required, anonymised analysis results can be presented to the Advisory Council for observation and evaluation. The first transmission according to Section 52b sub-section 3f AMG took place on 1 October 2021. In agreement with the Advisory Council, data is then subsequently requested regularly at two-month intervals. In individual cases, this cycle can either be shortened or extended after hearing of the Advisory Council.
The legal basis described here and its implementation allow the use of the transmitted data to monitor developments in production, distribution and demand. Accordingly, this is not purely a monitoring of supply shortages, but rather a prospective assessment and the earliest possible identification of potential deficits or problematic situations regarding finished medicinal products considered critical. Furthermore, the information gathered allows consideration of proactive strategies and targeted, coordinated measures in order to balance or prevent deficits or problem situations. If necessary, the BfArM will also coordinate targeted measures on a European level.
Further information is also available on the BfArM homepage in German.
Detail information on regular data transmission (German)