Medicines

Tips for changing to the new data sheet format

This document may be updated by Medsafe in response to further questions (check the version number to make sure you have the most recent document).

Please note that these are suggestions only. If you have wording that is more suitable to your product then this should be used.

If multiple strengths/dose forms for the same medicine are included in the data sheet, the strength/dose form does not need to be stated in the section title. A list of all the different strengths/dose forms should be created underneath the section title, one line for each different strength/dose form.

In instances where the excipients are different for different strengths/dose forms, it is suggested that a list is created using the same headings for the different strengths/dose forms as in section 1 and the excipients can then be listed separately.

Dosing information should not be repeated in section 4.4. Dosing information should be stated in section 4.2. Any warnings or precautions related to the need for different doses should be included in section 4.4 with a cross-reference to section 4.2.
Use of subheadings – the guidance suggests the use of subheadings for each different warning to facilitate readability. These should be used where necessary; however, it is not expected that all will apply in all instances. Subheadings have not been included in the template as it is expected that these will be unique for each product.

International Non-proprietary Names (INNs) should be used in the interactions section (and throughout the data sheet). This avoids the need to update the data sheet if the brand name changes. Information on interactions with unapproved medicines should be included as the interacting medicine may be supplied under section 25 or 29 or may be approved in the future.

Fertility subheading – this subheading should always be included whether or not you have fertility information. If you don’t have any information please state this under the heading (see also general comments below).

The driving warning wording in the explanatory guide are suggestions. More specific wording than these examples can be used.

System Organ Class (SOC) titles are standardised MedDRA terms and it is therefore advised that these are used in your Company Core Data Sheet (CCDS) for consistency with the data sheet and international product information.
The data sheet template has been updated to include the standard required information relating to the reporting of suspected adverse reactions.

The data sheet template has been updated to include the standard required information regarding advice on the management of overdose.
The guidance recommends that specific doses of other medicines are not mentioned as this may conflict with the data sheet of other products. Medicines used for treatment should be mentioned (using the INN). If this information is required the reader should refer to the data sheet for the other medicine.
Sponsors are recommended to review this section to ensure it is still current and remove any dose information for other medicines.

Clinical trial data should be placed in section 5.1 under the subheading clinical efficacy and safety.
If you wish to include the structure of the active and/or CAS numbers for example, these can be included in section 5.1.

Use of subheadings - these should be used where necessary however it is not expected that all will apply in all instances (see general comments below).
Information in section 4.4 should not be repeated in this section. It is expected that section 4.4 includes warnings and guidance on how clinicians should manage differences in pharmacokinetics and section 5.2 will include the technical pharmacokinetic information. If there is no technical pharmacokinetic information in the existing data sheet this isn’t expected to be included in the data sheet when reformatting.

Use of subheadings – headings and subheadings in bold in the explanatory guide must be present in all data sheets. If you hold no information, please state this under the bold heading.
Use of other - If you hold information for subheadings marked between arrows in the explanatory guide, this information must be included under the relevant . Where no information is held, other can be removed.
Reminder: there are no exemptions to the new format following 1 March 2017.

Version 1.0 April 2017