Manufacturer information data quality (update): Continuous improvement
Experience with the new forms; IDMP study; discontinuation of the one-off updating of manufacturer information
To improve the quality of manufacturer information, a new, comprehensive "Manufacturer Information" form (ZL000_00_002e_FO) was introduced in July 2016.
This form has since been supplemented by a new form for declaration(s) by the Responsible Person (RP) ("Responsible Person Declaration", ZL000_00_025e_FO) in order to ensure the standardised submission of the information. At the same time, questions and feedback from companies have been included in supplementary Explanations.
The experience with the new forms to date has been positive. By June 2017, over 2,700 new "Manufacturer information" forms had been submitted to Swissmedic in connection with new applications or variation applications; almost all the submitted forms are complete, providing information about all the companies involved in the manufacturer of a medicinal products, and thereby enabling us to improve the quality of the data.
The authorisation holder's RP bears sole responsibility for ensuring that the data is correct. Swissmedic checks the information through spot checks, for example during site inspections.
IDMP (Identification of Medicinal Products) – an unexceptional project to update manufacturer information
Since the autumn of 2016, as part of a study Swissmedic has been analysing the options for implementing electronic standards for the Identification of Medicinal Products (IDMP).
These standards use codification to ensure the unambiguous identification, electronic recording and transmission of all parameters for a medicinal product (e.g. identifier for the manufacturer, ingredient substances, pharmaceutical form, indications, etc.). Following the procedure in the EU, Swissmedic plans to introduce these standards in stages in a benefit-driven process. Top priority will be given to the electronic recording of technical data such as information relating to manufacturers and active substances.
On the basis of the above-mentioned study, Swissmedic has decided to discontinue the one-off updating of manufacturer information.
Manufacturer information will continue to be completed and updated on the basis of the forms required in connection with applications for authorisations and variations or in connection with market monitoring procedures. Following the introduction of the IDMP standards, scheduled for 2020, all manufacturer information will need to be newly coded and updated accordingly in a one-off process.
Swissmedic expects companies to have available at all times, and to be able to supply on request, all the information required in the new Manufacturer Information and RP Declaration forms. In individual cases, and according to a risk-based approach, Swissmedic will also request additional Manufacturer Information forms.