Adaptation of the Forms Renewal of authorisation HMV4

Further details in the chapter 3:

• The application for renewal of the authorisation in accordance with Art. 12 para. 1 TPO should be submitted together with the required documents and, where applicable, the discontinuation decision 1 year at the earliest but not later than 6 months before expiry of the authorisation.

Further details in chapter 5:

• For human medicinal products: Have the labelling and product information requirements in accordance with the revised TPLRO (especially full declaration as per Annex 3, Warnings about excipients of particular interest as per Annex 3, fixed texts as per Annex 4 and 5) already been implemented or, as the case may be, has the corresponding application been submitted to Swissmedic?
• For veterinary medicinal products: Have the labelling and product information requirements in accordance with the revised TPLRO (especially full declaration and adaptation of product information as per Annex 6) already been implemented or, as the case may be, has the corresponding application been submitted to Swissmedic?

Further details in the chapter 3:

• The application for renewal of the authorisation in accordance with Art. 12 para. 1 TPO should be submitted together with the required documents and, where applicable, the discontinuation decision 1 year at the earliest but not later than 6 months before expiry of the authorisation.

Further details in chapter 6:

• For human medicinal products: Have the labelling and product information requirements in accordance with the revised TPLRO (especially full declaration as per Annex 3, Warnings about excipients of particular interest as per Annex 3, fixed texts as per Annex 4 and 5) already been implemented or, as the case may be, has the corresponding application been submitted to Swissmedic?
• For veterinary medicinal products: Have the labelling and product information requirements in accordance with the revised TPLRO (especially full declaration and adaptation of product information as per Annex 6) already been implemented or, as the case may be, has the corresponding application been submitted to Swissmedic?

The new versions of the affected documents takes immediate effect.