Notification regarding Free Sale and Commerce Certificate for export of items not covered under Drugs & Cosmetics Act, 1940

TO BE PUBLISHED IN THE GAZETTE OF INDIA EXTRAORDINARY
(PART-I, SECTION-1)
GOVERNMENT OF INDIA
MINISTRY OF COMMERCE AND INDUSTRY
DEPARTMENT OF COMMERCE

PUBLIC NOTICE No. 137 (RE-2008) /2004-09
NEW DELHI: Dated the 19th January, 2009

1. In exercise of powers conferred under paragraph 2.4 of the Foreign Trade Policy, 2004-09, the Director General of Foreign Trade hereby makes, with immediate effect, the following amendments in the Handbook of Procedures, Vol. 1(RE-2008):

2. Sub-para at the end of Para 2.50 in the Handbook of Procedures Vol. I, relating to Free Sale an Commerce Certificate stands substituted as under:

“RAs may also issue, on application, Free Sale and Commerce Certificate for export of items not covered under Drugs & Cosmetics Act, 1940, which have usage in hospitals, nursing homes and clinics, for medical and surgical purposes and are not prohibited for export. Validity of such certificate shall be one year from date of issue unless otherwise specified.

Free Sale and Commerce Certificate shall be issued as per Annexure 1 to this Public Notice, based on application made under Appendix 39 and Annexure A of HBP Vol. I along with documents prescribed therein.”

3. Appendix 39 stands substituted and notified as amended Appendix 39 annexed with this Public Notice.

4. This issues in public interest.

Sd/-
(R.S. GUJRAL)
Director General of Foreign Trade
And Ex-Officio Additional Secretary to the Govt. of India

(Issued from File No.01/91/180/179/AM09/Export Cell)

Annexure - 1

Government of India
Ministry of Commerce & Industry
Department of Commerce
Directorate General of Foreign Trade

FREE SALE AND COMMERCE CERTIFICATE

The Medical Devices/Instruments as per Annexure (Total items) manufactured by M/s. (Name of the firm & full address) are freely exportable.

This certificate is valid for a period of one year from the date of issue.

Encl: As above.

Place:

Date:
Director General of Foreign Trade

Note: This certificate is based on declaration by the above firm that items of export shown in Annexure have usage in Hospital, Nursing Homes and Clinics for Medical Surgical Purpose and also that items of export shown in Annexure are neither banned nor prohibited for export. The items appearing in this certificate are also not covered under Drug & Cosmetics Act, 1940 as per declaration of the aforesaid firm.

Appendix 39
APPLICATION FOR FREE SALE & COMMERCE CERTIFICATE
1.
Name of the firm / Company
:
2.
Address of Registered Office
:
(i)
Tel No
:
(ii)
Fax No
:
(iii)
e.mail ID
3.
Importer Exporter Code No
:
(i) Code No.
(ii) Name & Address of issuing authority
4.
Registration –cum-Membership Certificate (RCMC ) details

(i) Name of the Council
(ii) Registration No and date
(iii) Validity
5.
Brief Description of exports
:
(i) Details of foreign buyer with complete address, e.mail ID etc.

(ii) Brief description of items to be exported under the certificate

6.
Whether the items of export fall under the Drugs & Cosmetics Act. 1940 . If so, indicate the same.
:
7.
Details of items for which Free Sale & Commerce Certificate is sought to be obtained (Annexure A to be attached duly self-certified)

8.
I hereby declare that items listed in Annexure A,
(i) are not prohibited or restricted for export under Schedule 2 of ITC (HS) and are free for export;

(ii) all the items listed in Annexure A have usage in hospitals, nursing homes and clinics, for medical and surgical purposes;

(iii) all the items listed above are not covered under Drugs & Cosmetics Act, 1940.


(Signature)
Name & Designation of the Authorized Signatory
Seal of the Company


DECLARATION / UNDERTAKING

1. I / We hereby declare that the particulars and the statements made in this application are true and correct to the best of my / our knowledge and belief and nothing has been concealed or held there from.
2. I / We fully understand that any information furnished in the application if found incorrect or false will render me / us liable for any penal action or other consequences as may be prescribed in law or otherwise warranted.
3. I / We undertake to abide by the provisions of the FT (D & R) Act, 1992, the Rules and Orders framed there under, FTP, HBP v 1 and HBP v2 and ITC (HS).

4. a. I / We hereby certify that the firm / company for whom the application has been made has not been penalized under Customs Act, Excise Act, FT (D & R) Act 1992 and FERA / FEMA.
b. I / We hereby certify that none of the Proprietor / Partner(s) / Director(s) / Karta / Trustee of firm / company, as the case may be, is / are a Proprietor / Partner(s) / Director(s) / Karta / Trustee in any other firm / Company which has come to adverse notice of DGFT.
c. I / We hereby certify that the Proprietor / Partner(s) / Director(s) / Karta / Trustee, as the case may be, of the firm/company is / are not associated as Proprietor / Partner(s) / Director(s) / Karta / Trustee in any other firm / company which is in the caution list of RBI.
d. I / We hereby certify that neither the Registered Office / Head Office of the firm/company nor any of its Branch Office(s) / Unit(s) / Division(s) has been declared a defaulter and has otherwise been made ineligible for undertaking import / export under any of the provisions of the Policy.

5. I / We hereby declare that I / We have not obtained nor applied for such benefits (including issuance of an Importer Exporter Code Number) in the name of our Registered / Head Office or any of our Branch(s) / Unit(s) / Division(s) to any other Regional Authority.
6. I / We hereby declare that I/we have perused the list of SCOMET items as contained in the Appendix 3 to the Schedule 2 of the ITC (HS) and that the item(s) exported / proposed to be exported does not fall within this list and that I / We agree to abide by the provisions of FTP for export of SCOMET items contained in the FTP, Schedule 2 of ITC (HS) and the HBP v1, irrespective of the scheme under which the item is exported / proposed to be exported.
7. I / We solemnly declare that I / We have applied for / obtained a RCMC to the EPC which pertains to our main line of business. In case we have applied to any other council, the application has been made within the purview of the provisions of Para 2.67 and Para 2.67.1 of the HBP v1.

8. I hereby certify that I am authorized to verify and sign this declaration as per Paragraph 9.9 of the Policy.

Signature of the Applicant Place
Name Date
Designation
Official Address
Telephone
Residential Address
Email Address

Note:

1. This form with Annexure -A may be submitted without other parts of the Aayat Niryat Form.

2 .For items falling under the Drug & Cosmetics Act, 1940, application for issue of Free Sale & Commerce Certificate may be made to the Drug Controller General (I), Directorate General of Health Services, Ministry of Health & Family Welfare, FDA Bhawan, Kotla Rod, Near Mata Sundari Collage, ITO, New Delhi- 110002.
Annexure - A

Proforma for Submission of list of Products
(May be clearly typed)