The various product list options that apply to the respect licence types are listed below. Expand the title of any licence type to gain access to the guidance.
Licence Types DL01, DR01 OPTION 1: IN THE CASE OF LISTING PRODUCTS:TEMPLATE FOR LICENCE PRODUCT LIST(v07-20) Option 1 required for manufacturers who are prospective holders of a certificate of registration. If option 1 is used, products entered must comply with the definition of a complementary medicine, must be categorised correctly and the selected risk profile must match the indication provided. AND/OR OPTION 2: IN THE CASE OF CONTRACT MANUFACTURERS OF PRODUCTS OWNED BY LICENSED COMPANIES: TEMPLATE FOR LICENCE PRODUCT LIST - LIST OF LICENSED ENTITIES (v12-21) If option 2 is used, companies with whom the applicant holds technical agreements in respect of the manufacturing of Category D medicines must be listed. These companies must be licensed and their licence number stated at the time of entry. The lists in option 2 may be amended at any time and are not subject to a fee. The licence condition shall be that only Category D medicines will be associated with the companies identified, failing which the licence will be revoked. An applicant may make use of option 1 or option 2, or any combination thereof at their own discretion and in line with their own compliance. Only complete the yellow shaded fields. Cell headings provide for the type of entry and instructions for each column. Text may be copied to cells with drop down lists but the pasted text must utilise the exact spelling/wording of the selected option of the drop down list. Licence Types DL02, DR02 The applicant must download and complete the TEMPLATE FOR LICENCE PRODUCT LIST (v07-20) for the list of medicines/scheduled substances that are manufactured, imported, exported, or stored at/from this site(s).
Licence Types DL03, DR03 The applicant must download and complete any combination of the following documents for the list of medicines/scheduled substances that are stored at/from this site(s):
OPTION 1: IN THE CASE OF LISTING PRODUCTS: TEMPLATE FOR LICENCE PRODUCT LIST(v07-20) If option 1 is used, products entered must comply with the definition of a complementary medicine, must be categorised correctly and the selected risk profile must match the indication provided. AND/OR OPTION 2: IN THE CASE OF IDENTIFICATION OF COMPANIES (LICENSED OR UNLICENSED): TEMPLATE FOR LICENCE PRODUCT LIST - LIST OF SUPPLIERS (v12-21) If option 2 is used, companies with whom the applicant holds technical agreements in respect of the wholesaling or distribution of Category D medicines must be listed. These companies may be licensed (in which case their licence number should be stated) or unlicensed at the time of entry. The lists in option 2 may be amended at any time and are not subject to a fee. The licence condition shall be that only Category D medicines will be associated with the companies identified, failing which the licence will be revoked. An applicant may make use of option 1 and option 2, or either of option 1 or option 2 at their own discretion and in line with their own compliance. Only complete the yellow shaded fields. Cell headings provide for the type of entry and instructions for each column. Text may be copied to cells with drop down lists but the pasted text must utilise the exact spelling/wording of the selected option of the drop down list. OPTION 1: IN THE CASE OF LISTING PRODUCTS: TEMPLATE FOR LICENCE PRODUCT LIST(v07-20) Option 1 required for all prospective holders of a certificate of registration. Option 1 may also be used by manufacturers or wholesalers who choose to have products listed. If option 1 is used, products entered must comply with the definition of a complementary medicine, must be categorised correctly and the selected risk profile must match the indication provided. OPTION 2: IN THE CASE OF CONTRACT MANUFACTURERS OF PRODUCTS OWNED BY LICENSED COMPANIES: TEMPLATE FOR LICENCE PRODUCT LIST - LIST OF LICENSED ENTITIES (v12-21) Option 2 may be used (alone or together with Option 1) by contract manufacturers. If option 2 is used, companies with whom the applicant holds technical agreements in respect of the manufacturing of Category D medicines must be listed. These companies must be licensed and their licence number stated at the time of entry. The lists in option 2 may be amended at any time and are not subject to a fee. The licence condition shall be that only Category D medicines will be associated with the companies identified, failing which the licence will be revoked. OPTION 3: IN THE CASE OF IDENTIFICATION OF COMPANIES (LICENSED OR UNLICENSED): TEMPLATE FOR LICENCE PRODUCT LIST - LIST OF SUPPLIERS (v12-21) Option 3 may be used (alone or together with Option 1) by wholesalers. If option 3 is used, companies with whom the applicant holds technical agreements in respect of the wholesaling or distribution of Category D medicines must be listed. These companies may be licensed (in which case their licence number should be stated) or unlicensed at the time of entry. The lists in option 3 may be amended at any time and are not subject to a fee. The licence condition shall be that only Category D medicines will be associated with the companies identified, failing which the licence will be revoked.
The applicant must download and complete any combination of the following documents for the list of medicines/scheduled substances that are stored at/from this site(s):
Products entered must comply with the definition of a complementary medicine, must be categorised correctly and the selected risk profile must match the indication provided.
Only complete the yellow shaded fields (which will turn white with text entered). Cell headings provide for the type of entry for each column. Text may be copied to cells with drop down lists but the pasted text must utilise the exact spelling/wording of the selected option of the drop down list.
Licence Types DA01, DA02