Medicines (Licensing, Standard Provisions and Fees) Regulations

Source: Singapore Statutes Online | Archived by Legal Wires

Medicines Act
(CHAPTER 176, Section 74)
Medicines (Licensing, Standard Provisions and Fees) Regulations
Rg 6
G.N. No. S 174/1987

REVISED EDITION 2000
(31st January 2000)
[30th June 1987]
Citation
1.  These Regulations may be cited as the Medicines (Licensing, Standard Provisions and Fees) Regulations.
Definitions
2.  In these Regulations —
“Authority’s website” means the Authority’s Internet website at http://www.hsa.gov.sg;
“Chinese proprietary medicine” has the same meaning as in the Medicines (Traditional Medicines, Homoeopathic Medicines and other Substances) (Exemption) Order (O 6);
“competent drug regulatory agency” means a national regulatory authority participating in the World Health Organization’s Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, and listed as such on the World Health Organization’s website;
“licensing authority” means the Chief Executive of the Authority;
“major variation”, in relation to a medicinal product, means any change to the product specifications of the medicinal product that relate to any of the following:
(a)the indications of the medicinal product;
(b)the dosage recommendations of the medicinal product;
(c)the patient groups for the medicinal product;
(d)clinical trial information on the medicinal product;
“psychotropic substance” has the same meaning as in the Medicines (Export Licence for Psychotropic Substances) Regulations (Rg 9);
“reference drug regulatory agency” means a national regulatory authority, specified by the Authority on the Authority’s website, from whose regulatory decisions the Authority takes reference.
[S 547/2016 wef 01/11/2016]
Standard provisions for licences
3.—(1)  Subject to paragraph (2), the standard provisions for licences (including provisional licences) to be granted under Part II of the Act shall be the following:
(a)for product licences, those provisions set out in the First Schedule;
(b)for import licences, those provisions set out in the Second Schedule;
(c)for wholesale dealer’s licences, those provisions set out in the Third Schedule; and
(d)for manufacturer’s licences, those provisions set out in the Fourth Schedule.
(2)  The standard provisions for import licences to be granted under Part II of the Act in respect of Chinese proprietary medicines shall be as follows:
(a)those provisions set out in the Second Schedule except paragraphs 8, 9(2) and 11;
(b)the provision that the holder of the licence shall seek the prior approval of the licensing authority to deal with any medicinal product under his licence, and he shall, within such time as the licensing authority may specify, provide such information and documents as may be required by the licensing authority;
(c)the provision that the holder of the licence shall not import, sell or supply any medicinal product to which the licence relates unless —
(i)the approval of the licensing authority to deal with that medicinal product under his licence continues to be valid at the time of the import, sale or supply, as the case may be, of the medicinal product; and
(ii)he complies with any written law applicable to the import, sale or supply, as the case may be, of the medicinal product; and
(d)the provision that the holder of the licence shall not sell or supply any medicinal product to which the licence relates unless and until he has submitted to the licensing authority the following documents within 2 months of the import of the consignment of the medicinal product —
(i)a declaration of the absence of any poison as defined in the Poisons Act (Cap. 234) and any synthetic active substance in the medicinal product;
(ii)test results on the content of all the substances specified in the First Schedule to the Medicines (Prohibition of Sale and Supply) Order (O 4) in the medicinal product;
[S 413/2019 wef 01/09/2019]
(iii)where the medicinal product is for oral consumption, test results on the content of Escherichia coli, Salmonella, Staphylococcus aureus, *the total yeast and mould count, and *the total aerobic microbial count per gram or millilitre of the medicinal product (*not necessary if the medicinal product contains any active substance which is derived from plants, animals or a combination thereof and which has been produced by fermentation processes);
[S 621/2003 wef 01/01/2004]
(iv)where the medicinal product is for external application, test results on the content of Pseudomonas aeruginosa, Staphylococcus aureus, *the total yeast and mould count, and *the total aerobic microbial count per gram or millilitre of the medicinal product (*not necessary if the medicinal product contains any active substance which is derived from plants, animals or a combination thereof and which has been produced by fermentation processes) ; and
[S 621/2003 wef 01/01/2004]
(v)such other documents and test results as may be required by the licensing authority.
[S 621/2003 wef 01/01/2004]
(3)  The standard provisions for wholesale dealer’s licences to be granted under Part II of the Act in respect of Chinese proprietary medicines shall be those provisions set out in the Third Schedule except that paragraph 6 thereof shall read as if the words “or by the holder of the product licence” in the second line have been deleted.
(4)  The standard provisions for manufacturer’s licences to be granted under Part II of the Act in respect of Chinese proprietary medicines shall be —
(a)those provisions set out in the Fourth Schedule, except for paragraph 4(b) thereof and except that —
(i)paragraph 4(a) thereof shall read as if the words “under the relevant product licences” at the end thereof have been deleted; and
(ii)paragraph 12 thereof shall read as if the words “, except so far as the conditions of the relevant medicinal product licence may otherwise provide,” in the third and fourth lines have been deleted;
[S 309/2001 wef 01/09/2001]
(b)the provision that the holder of the licence shall seek the prior approval of the licensing authority to deal with any medicinal product under his licence, and he shall, within such time as the licensing authority may specify, provide such information and documents as may be required by the licensing authority;
(c)the provision that the holder of the licence shall not manufacture, assemble, sell or supply any medicinal product to which the licence relates unless —
(i)the approval of the licensing authority to deal with that medicinal product under his licence continues to be valid at the time of the manufacture, assembly, sale or supply, as the case may be, of the medicinal product; and
(ii)he complies with any written law applicable to the manufacture, assembly, sale or supply, as the case may be, of the medicinal product; and
(d)the provision that the holder of the licence shall inform the licensing authority of any decision to cease the manufacture or assembly of the medicinal product to which the licence relates and shall state the reason for that decision.
Grant of licences
4.—(1)  Every product licence, wholesale dealer’s licence and manufacturer’s licence granted shall be for a period of one year or such shorter period as specified in that licence.
(2)  Every import licence granted to any person authorised by the holder of a product licence shall be for a period of one year or such shorter period as specified in the licence.
(3)  Every import licence granted to any person not authorised by the holder of a product licence shall be on a per consignment basis.
(4)  Notwithstanding paragraphs (2) and (3), every import licence granted in respect of Chinese proprietary medicines shall be for a period of one year or such shorter period as specified in the licence.
[S 416/2005 wef 01/07/2005]
Fees
5.—(1)  The fees in respect of applications for, and the grant of, licences and certificates and for any variation or amendment thereof shall be as specified in the Fifth Schedule.
(2)  No refund shall be made in respect of any fee paid under these Regulations.
Cost of evaluation
5A.  Where for the purpose of dealing with an application for the grant or variation of a product licence the Authority conducts any assessment or evaluation of any medicinal product, the cost of the assessment or evaluation shall, unless otherwise required by the Authority, be borne by the person making the application.
[S 641/2002 wef 20/12/2002]
5B.  [Deleted by S 547/2016 wef 01/11/2016]
Offences
6.  A holder of a licence who contravenes or fails to comply with any standard provision applicable to his licence shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $5,000 or to imprisonment for a term not exceeding 2 years or to both.
FIRST SCHEDULE
Regulation 3(1)(a)
Standard provisions for product licence
1.  The holder of the licence shall forthwith report to the licensing authority any change in his name and address and in any address at which there is carried on a business to which the licence relates.
2.—(1)  The holder of the licence shall forthwith inform the licensing authority of any material change that has been made or that he proposes to make in the particulars contained in his application, in relation to any medicinal product to which the licence relates, that is to say —
(a)in the specification of the medicinal product;
(b)in the specification of any of the constituents of the medicinal product;
(c)in the composition of the medicinal product, or of any of the constituents of the medicinal product;
(d)in the methods of manufacture or assembly of the medicinal product, or of any of the constituents of the medicinal product;
(e)in the methods and procedures described in the application for ensuring compliance with the specifications relating to the medicinal product;
(f)in the arrangements described in the application for storage of the medicinal product;
(g)in the indications for use of the medicinal product; and
(h)in the contents of any label affixed to or displayed on the container or package of the medicinal product or in the contents of any leaflet relating to the medicinal product enclosed in the container or package of the medicinal product.
(2)  The holder of the licence shall forthwith inform the licensing authority of any change to a material extent in the licence that he proposes to make.
3.  The holder of the licence shall forthwith inform the licensing authority of any information received by him that casts doubt on the continued validity of the data which was submitted with, or in connection with, his application for a product licence for the purpose of being taken into account in assessing the safety, quality or efficacy of any medicinal product to which the licence relates.
4.  The holder of the licence shall inform the licensing authority within 7 days upon receipt of any report of which he is aware of adverse effects in one or more human beings associated in that report resulting from the use of any medicinal product to which the licence relates, which shall be open to inspection by a person authorised by the licensing authority, who may take copies thereof and, if the licensing authority so directs, the holder of the licence shall furnish the licensing authority with a copy of any such report of which he has a record or of which he is or subsequently becomes aware.
[S 547/2016 wef 01/11/2016]
5.—(1)  The holder of the licence shall —
(a)keep readily available for inspection by a person authorised by the licensing authority records in such form as the licensing authority may require; and
(b)permit the person authorised to take copies of or to make extracts from such records.
(2)  The records shall not be destroyed without the consent of the licensing authority for a period of 2 years from the date when the importation, sale, supply or exportation of the relevant batch of the medicinal product was authorised by or on behalf of the holder of the licence.
(3)  Records for the supply of commercial samples of medicinal products containing any item which is listed in the Poisons List in the Schedule to the Poisons Act (Cap. 234) shall also be kept in such form as the licensing authority may require.
6.  When the holder of the licence has been informed by the licensing authority that any batch of any medicinal product to which the licence relates has been found to be harmful or unsafe or not to conform as regards strength, quality or purity with the specification of that medicinal product, the holder of the licence shall, if so directed, withhold such batch from sale, supply or exportation, so far as may be reasonably practicable, for such period as may be specified by the licensing authority and withdraw the defective products from the market immediately if the licensing authority requests him to do so.
7.  The holder of the licence shall notify the licensing authority forthwith of any decision to withdraw from sale, supply or exportation any medicinal product to which the licence relates, and shall state the reason for that decision.
8.  The holder of the licence shall state the licence number designated by the licensing authority on the label and package accompanying the product.
9.  The holder of the licence shall return the original copy of the licence to the licensing authority within 7 days of the date on which the licence has been suspended or revoked.
10.  The holder of the licence shall not use the licence for advertising purposes.
11.  The holder of the licence shall undertake to arrange such tests as may be required by the licensing authority and shall submit samples if so requested by the licensing authority.
[G.N. Nos. S 174/87; S 345/87; S 277/92; S 99/96; S 387/97; S 496/98; S 587/99]
SECOND SCHEDULE
Regulation 3(1)(b)
Standard provisions for import licence
1.  The holder of the licence shall forthwith report to the licensing authority any change in his name and address and in any address at which there is carried on a business to which the licence relates.
2.  The holder of the licence shall undertake to arrange such tests as may be required by the licensing authority and shall submit samples if so requested by the licensing authority.
3.  The holder of the licence shall forthwith inform the licensing authority of any material change that has been made in the particulars contained in his application, in relation to any medicinal product to which the licence relates, that is to say —
(a)in the specification of the medicinal product;
(b)in the specification of any of the constituents of the medicinal product;
(c)in the composition of the medicinal products, or of any of the constituents of the medicinal product; or
(d)in the manufacture of the medicinal product.
4.  When the holder of the licence has been informed by the licensing authority that any batch of any medicinal product to which the licence relates has been found to be harmful or unsafe or not to conform as regards strength, quality or purity with the specification of that medicinal product, the holder of the licence shall, if so directed, withhold such batch from sale, supply or exportation, so far as may be reasonably practicable, for such period as may be specified by the licensing authority and withdraw the defective medicinal product from the market immediately if the licensing authority requests him to do so.
5.—(1)  The holder of the licence shall keep readily available for inspection by a person authorised by the licensing authority records in such form as the licensing authority may require.
(2)  The records shall not be destroyed for a period of 2 years from the date of importation, sale, supply or exportation of the medicinal product without the consent of the licensing authority.
(3)  The holder of the licence shall permit a person authorised by the licensing authority to take copies of or to make extracts from such records.
(4)  Records for the supply of commercial samples of medicinal products containing any item which is listed in the Poisons List in the Schedule to the Poisons Act (Cap. 234) shall also be kept in such form as the licensing authority may require.
6.  The holder of the licence shall inform the licensing authority of any decision to withdraw the importation, sale or supply of the medicinal product to which the licence relates, and shall state the reason for that decision.
7.  The holder of the licence shall inform the licensing authority within 7 days upon receipt of any report of which he is aware of adverse effects in one or more human beings associated in that report resulting from the use of any medicinal product to which the licence relates, which shall be open to inspection by a person authorised by the licensing authority, who may take copies thereof and, if the licensing authority so directs, the holder of the licence shall furnish the licensing authority with a copy of any such report of which he has a record or of which he is or subsequently becomes aware.
[S 547/2016 wef 01/11/2016]
8.  The holder of the licence on a per consignment basis shall state the licence number designated by the licensing authority on the label and package accompanying the product.
9.—(1)  The holder of the licence shall return the original copy of the licence to the licensing authority within 7 days of the date on which the licence has been suspended or revoked.
(2)  The holder of the licence on a per consignment basis shall return the licence to the licensing authority within 7 days of that consignment has been imported.
10.  The holder of the licence shall not use the licence for advertising purposes.
11.  The validity of the import licence, in respect of each medicinal product which the importer is dealing in, shall be subject to the continued validity of the corresponding product licence.
THIRD SCHEDULE
Regulation 3(1)(c)
Standard provisions for wholesale dealer’s licence
1.  The holder of the licence shall provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the medicinal products which he handles, stores or distributes under his licence, as are necessary to avoid deterioration of the medicinal products and he shall not use for such purposes premises other than those specified in the licence or which may be approved from time to time by the licensing authority.
2.  The holder of the licence shall provide such information as may be requested by the licensing authority concerning the type and quality of any medicinal product which he handles, stores or distributes.
3.  The holder of the licence shall inform the licensing authority of any proposed structural alteration to, or discontinuance of use of, any premises to which the licence relates or any premises which are approved from time to time by the relevant licensing authority.
4.  The holder of the licence shall keep in his business premises such documents relating to his transactions by way of the sale of medicinal products to which the licence relates as will facilitate the withdrawal or recall from sale or exportation of such products.
5.—(1)  The holder of the licence shall keep readily available for inspection by a person authorised by the licensing authority records in such form as the licensing authority may require.
(2)  The records shall not be destroyed without the consent of the licensing authority for a period of 2 years from the date of receipt, sale, supply or exportation of the medicinal product.
(3)  The holder of the licence shall permit the person authorised by the licensing authority to take copies of or to make extracts from such records.
(4)  Records for the supply of commercial samples of medicinal products containing any item which is listed in the Poisons List in the Schedule to the Poisons Act (Cap. 234) shall also be kept in such form as the licensing authority may require.
6.  Where the holder of the licence has been informed by the licensing authority or by the holder of the product licence that any batch of any medicinal product to which the wholesale dealer’s licence relates has been found to be harmful or unsafe or not to conform as regards strength, quality or purity with the specification of that product or with the provisions of the Act or any regulations made thereunder that are applicable to the medicinal product, the holder of the licence shall, if so directed, withhold such batch from sale, supply or exportation, so far as may be reasonably practicable, for such period as may be specified by the licensing authority and withdraw the defective medicinal product from the market immediately if the licensing authority requests him to do so.
7.  The holder of the licence shall return the original copy of the licence to the licensing authority within 7 days of the date on which the licence has been suspended or revoked.
8.  The holder of the licence shall not use the licence for advertising purposes.
FOURTH SCHEDULE
Regulation 3(1)(d)
Standard provisions for manufacturer’s licence
1.  The holder of the licence shall forthwith report to the licensing authority any change in his name and address and in any address at which there is carried on a business to which the licence relates.
2.  The holder of the licence shall provide and maintain such staff, premises, equipment and plant as are necessary for the carrying out in accordance with his licence and the relevant product licences of such stages of the manufacture and assembly of the medicinal products as are undertaken by him, and he shall not carry out any such manufacture or assembly except at the premises specified in his licence.
3.  The holder of the licence shall provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the medicinal products which he handles, stores or distributes under his licence as are necessary to avoid deterioration of the medicinal products and he shall not use for such purposes premises other than those specified in his licence or which may be approved from time to time by the licensing authority.
4.  The holder of the licence shall —
(a)conduct all manufacture and assembly operations in such a way as to ensure that the medicinal products are of the correct identities and conform with the standards of strength, quality and purity applicable to them under the relevant product licences; and
(b)comply with the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products, as revised or amended from time to time.
[S 309/2001 wef 01/09/2001]
5.  The holder of the licence shall carry out or cause to be carried out tests on the strength, quality or purity of the medicinal products to ensure that the standard of the medicinal products that he manufactures under his manufacturer’s licence is complied with.
5A.  Where the holder of the licence does not carry out the tests referred to in paragraph 5 himself, he shall engage a testing laboratory that is approved by the licensing authority to carry out the tests.
[S 309/2001 wef 01/09/2001]
6.  The holder of the licence shall provide such information, as may be requested by the licensing authority for the purposes of the Act, in respect of the products currently being manufactured or assembled under his licence and of the operations being carried out in relation to such manufacture or assembly.
7.  Where the manufacturer’s licence relates to the assembly of a medicinal product and that medicinal product is not manufactured by the holder of the licence, and where the particulars as to the name and address of the manufacturer of, or of the person who imports, that medicinal product had been given by the holder of the licence to the licensing authority, the holder of the licence shall forthwith notify the licensing authority in writing of any changes in the particulars.
8.—(1)  The holder of the licence shall inform the licensing authority before making any material alteration to the premises or plant used under his licence, or in the operations for which they are used.
(2)  The holder of the licence shall inform the licensing authority of any change that he proposes to make in any personnel named in his application form as respectively —
(a)responsible for supervising the production operations; or
(b)responsible for quality control of the medicinal products being manufactured or assembled.
9.—(1)  The holder of the licence shall keep readily available for inspection by a person authorised by the licensing authority durable records of the details of manufacture and assembly of each batch of every medicinal product being manufactured or assembled under his licence and of the tests carried out thereon, in such form as the licensing authority may require such that the records will be easily identifiable from the number of the batch as shown on each container in which the medicinal product is sold, supplied or exported.
(2)  The holder of the licence shall permit the person authorised to take copies of or to make extracts from the records.
(3)  Such records shall not be destroyed for a period of 2 years from the date when the manufacture or assembly of the relevant batch occurred without the consent of the licensing authority.
10.  The holder of the licence shall keep such records as will facilitate the withdrawal or recall from sale, supply or exportation of any medicinal product to which the licence relates.
11.  Where the holder of the licence has been informed by the licensing authority or where he has reason to suspect that any batch of any medicinal product to which his licence relates has been found to be harmful or unsafe or not to conform as regards strength, quality or purity with the specification of the relevant medicinal product, the holder of the licence shall, if so directed, withhold such batch from sale, supply or exportation, for such a period as may be specified by the licensing authority and withdraw the defective medicinal product from the market immediately if the licensing authority requests him to do so.
12.  The holder of the licence shall ensure that any tests for determining conformity with the standards and specifications applying to any particular medicinal product used in the manufacture shall, except so far as the conditions of the relevant medicinal product licence may otherwise provide, be applied to samples taken from the medicinal product after all manufacturing processes have been completed, or at such earlier stage in the manufacture as may be approved by the licensing authority.
13.  The holder of the licence shall inform the licensing authority within 7 days upon receipt of any report of which he is aware of any adverse effect in one or more human beings associated in that report resulting from the use of any medicinal product to which the licence relates, which shall be open to inspection by any person authorised by the licensing authority, who may take copies thereof and, if the licensing authority so directs, the holder of the licence shall furnish the licensing authority with a copy of any such report of which he has a record or of which he subsequently becomes aware.
[S 547/2016 wef 01/11/2016]
14.  The holder of the licence shall return the original copy of the licence to the licensing authority within 7 days of the date on which the licence has been suspended or revoked.
15.  The holder of the licence shall not use the licence for advertising purposes.
FIFTH SCHEDULE
Regulation 5
FEES
1.PRODUCT LICENCE
(1)Application for a product licence for —
 
 
(a)a medicinal product that has not yet been approved by any competent drug regulatory agency and is therefore required by the Authority to undergo full evaluation:
 
 
(i)application fee for the initial screening#
 
$3,060
(ii)evaluation fee*
 
$83,100
(b)a medicinal product that has been approved by at least one competent drug regulatory agency and is therefore allowed by the Authority to undergo abridged evaluation:
 
 
(i)application fee for the initial screening#
 
$610
(ii)evaluation fee* for a single‑strength product or the first product in a series of products of different strengths
 
$11,600
(iii)evaluation fee* for each subsequent product in a series of products of different strengths
 
$6,030
(c)a medicinal product that has been approved by a reference drug regulatory agency and is therefore allowed by the Authority to undergo verification evaluation:
 
 
(i)application fee for the initial screening#
 
$610
(ii)evaluation fee* for a single‑strength product or the first product in a series of products of different strengths
 
$17,100
(iii)evaluation fee* for each subsequent product in a series of products of different strengths
 
$6,030
(2)Licence fee for —
 
 
(a)the first year of the term of a product licence
 
Nil
(b)each subsequent year of the term of a product licence
 
$330
(3)Application to amend a product licence —
 
 
(a)to make a major variation, where the application is required to undergo full evaluation by the Authority:
 
 
(i)application fee for the initial screening#
 
$2,780
(ii)evaluation fee*
 
$51,600
(b)to make a major variation, where the application can be reviewed by the Authority through abridged evaluation:
 
 
(i)application fee for the initial screening#
 
$560
(ii)evaluation fee* for a single‑strength product or the first product in a series of products of different strengths
 
$6,030
(iii)evaluation fee* for each subsequent product in a series of products of different strengths
 
$3,060
(c)to make a major variation, where the application can be reviewed by the Authority through verification evaluation:
 
 
(i)application fee for the initial screening#
 
$560
(ii)evaluation fee* for a single‑strength product or the first product in a series of products of different strengths
 
$8,850
(iii)evaluation fee* for each subsequent product in a series of products of different strengths
 
$3,060
(d)to make any other variations to the product specifications of a medicinal product:
 
 
(i)application fee#
 
$610
(ii)evaluation fee
 
Nil
2.IMPORT LICENCE (INCLUDING FOR CHINESE PROPRIETARY MEDICINES)
 
 
(1)Application fee for an import licence
 
$560
(2)Licence fee for —
 
 
(a)the first year of the term of an import licence
 
Nil
(b)each subsequent year of the term of an import licence
 
$560
(3)Application fee to amend an import licence —
 
 
(a)with site inspection^
 
$330
(b)without site inspection^
 
$57
3.WHOLESALE DEALER’S LICENCE (INCLUDING FOR CHINESE PROPRIETARY MEDICINES)
 
 
(1)Application fee for a wholesale dealer’s licence
 
$560
(2)Licence fee for —
 
 
(a)the first year of the term of a wholesale dealer’s licence
 
Nil
(b)each subsequent year of the term of a wholesale dealer’s licence
 
$560
(3)Application fee to amend a wholesale dealer’s licence —
 
 
(a)with site inspection^
 
$330
(b)without site inspection^
 
$57
4.MANUFACTURER’S LICENCE (INCLUDING FOR CHINESE PROPRIETARY MEDICINES)
 
 
(1)Application fee for a manufacturer’s licence for —
 
 
(a)manufacture of external preparations only
 
$1,670
(b)manufacture of oral preparations only
 
$1,670
(c)manufacture of external and oral preparations only
 
$2,230
(d)manufacture of sterile preparations, or other types of dosage forms or dosage form combinations not described in sub‑paragraphs (a), (b) and (c), if the medicinal product is not a Chinese proprietary medicine
 
$3,340
(e)primary assembly of a medicinal product
 
$1,110
(f)secondary assembly of a medicinal product
 
$660
(2)Licence fee for —
 
 
(a)the first year of the term of a manufacturer’s licence
 
Nil
(b)each subsequent year of the term of a manufacturer’s licence for —
 
 
(i)manufacture of external preparations only
 
$1,670
(ii)manufacture of oral preparations only
 
$1,670
(iii)manufacture of external and oral preparations only
 
$2,230
(iv)manufacture of sterile preparations, or other types of dosage forms or dosage form combinations not described in sub-paragraphs (i), (ii) and (iii), if the medicinal product is not a Chinese proprietary medicine
 
$3,340
(v)primary assembly of a medicinal product
 
$1,110
(vi)secondary assembly of a medicinal product
 
$660
(3)Application fee to amend a manufacturer’s licence —
 
 
(a)with site inspection^ (for a licence to manufacture a medicinal product)
 
$1,110
(b)with site inspection^ (for a licence to assemble a medicinal product)
 
$560
(c)without site inspection^
 
$57
5.CERTIFICATES AND DOCUMENTS (NON‑MANDATORY)
 
 
(1)Application fee for a Certificate to Export a Medicinal Product
 
$111
(2)Application fee for a Certificate to Export a Chinese Proprietary Medicine
 
$111
(3)Application fee for a Confirmation of Authorisation to Import a Psychotropic Substance
 
$111
(4)Application fee for a Confirmation of Authorisation to Import a Restricted Substance
 
$111
____________________
#Fee is payable upon submission of application.
*Fee is payable upon acceptance of application.
^Refer to the Authority’s guidance notes on amendment applications for licences (available at the Authority’s website) to find out if a site inspection is required.
[S 492/2024 wef 01/07/2024]
SIXTH SCHEDULE
[Deleted by S 547/2016 wef 01/11/2016]

LEGISLATIVE HISTORY

Medicines (Licensing, Standard Provisions and Fees) Regulations

 

This Legislative History is provided for the convenience of users of the Medicines (Licensing, Standard Provisions and Fees) Regulations. It is not part of these Regulations.
1.  
G. N. No. S 174/1987—Medicines (Licensing, Standard Provisions and Fees) Regulations 1987
Date of commencement
:
30 June 1987
2.  
G. N. No. S 345/1987—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 1987
Date of commencement
:
24 December 1987
3.  
1990 Revised Edition—Medicines (Licensing, Standard Provisions and Fees) Regulations
Date of operation
:
25 March 1992
4.  
G. N. No. S 277/1992—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 1992
Date of commencement
:
1 July 1992
5.  
G. N. No. S 99/1996—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 1996
Date of commencement
:
1 April 1996
6.  
G. N. No. S 387/1997—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 1997
Date of commencement
:
1 October 1997
7.  
G. N. No. S 496/1998—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 1998
Date of commencement
:
1 September 1999
8.  
G. N. No. S 587/1999—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 1999
Date of commencement
:
1 January 2000
9.  
2000 Revised Edition—Medicines (Licensing, Standard Provisions and Fees) Regulations
Date of operation
:
31 January 2000
10.  
G. N. No. S 309/2001—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2001
Date of commencement
:
1 September 2001
11.  
G. N. No. S 641/2002—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2002
Date of commencement
:
20 December 2002
12.  
G. N. No. S 621/2003—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2003
Date of commencement
:
1 January 2004
13.  
G. N. No. S 384/2004—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2004
Date of commencement
:
1 July 2004
14.  
G. N. No. S 416/2005—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2005
Date of commencement
:
1 July 2005
15.  
G. N. No. S 499/2005—Medicines (Licensing, Standard Provisions and Fees) (Amendment No. 2) Regulations 2005
Date of commencement
:
1 August 2005
16.  
G. N. No. S 558/2005—Medicines (Licensing, Standard Provisions and Fees) (Amendment No. 3) Regulations 2005
Date of commencement
:
1 September 2005
17.  
G. N. No. S 681/2005—Medicines (Licensing, Standard Provisions and Fees) (Amendment No. 4) Regulations 2005
Date of commencement
:
1 November 2005
18.  
G. N. No. S 821/2005—Medicines (Licensing, Standard Provisions and Fees) (Amendment No. 5) Regulations 2005
Date of commencement
:
1 January 2006
19.  
G. N. No. S 648/2006—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2006
Date of commencement
:
1 December 2006
20.  
G. N. No. S 28/2007—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2007
Date of commencement
:
1 February 2007
21.  
G. N. No. S 510/2010—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2010
Date of commencement
:
15 September 2010
22.  
G. N. No. S 693/2010—Medicines (Licensing, Standard Provisions and Fees) (Amendment No. 2) Regulations 2010
Date of commencement
:
1 January 2011
23.  
G. N. No. S 547/2016—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2016
Date of commencement
:
1 November 2016
24.  
G.N. No. S 97/2019—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2019
Date of commencement
:
2 April 2019
25.  
G.N. No. S 413/2019—Medicines (Licensing, Standard Provisions and Fees) (Amendment No. 2) Regulations 2019
Date of commencement
:
1 September 2019
26.  
G.N. No. S 461/2022—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2022
Date of commencement
:
1 July 2022
27.  
G.N. No. S 492/2024—Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2024
Date of commencement
:
1 July 2024

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