N.J. Admin. Code § 8:21-1.10 - Certificate of Free Sale application process, fees, appeal process
(a) An entity desiring
to obtain a Certificate of Free Sale shall make application to the Commissioner of
the Department of Health for a Certificate of Free Sale or any other certificate or
affidavit, on forms approved by the Department, in accordance with the requirements
of this section. Certificate of Free Sale application forms may be obtained by
writing to the following address:
Public Health and Food Protection Program
Consumer, Environmental, and Occupational Health Service
Department of Health
PO Box 369
Trenton, NJ 08625-0369
(b) Each application shall be for a single
Certificate of Free Sale that will address up to, but no more than, 25 specific
food, drug, cosmetic or medical device products regulated under Title 24 of the New
Jersey Statutes and manufactured, distributed and offered for sale in this State and
labeled in conformance with the applicable food, drug, cosmetic or medical device
laws.
(c) Applicants for a Certificate
of Free Sale shall:
1. Submit a self-addressed and
stamped envelope, air bill or equivalent;
2. Provide the applicant's business name and
mailing address and the name and telephone number of a contact person;
3. Type and complete the application
form;
4. Certify that the product or
products for which a Certificate of Free Sale is sought is for sale or available for
sale and not under embargo, seizure or other restraint;
5. Submit the nonrefundable fee specified at (f)
below by means of certified check or money order, made payable to the Department of
Health;
6. Submit complete product
labels for each product for which a Certificate of Free Sale is sought;
i. Labels shall meet the requirements of
applicable State and Federal labeling requirements; and
7. Provide other documentation as requested by the
DHSS to substantiate that the product is not under embargo, seizure or other
restraint and to attest to the validity of the product and its contents.
(d) Applicants for Certificates of Free
Sale whose applications have been denied shall have 60 days from the date of denial
to meet the requirements of this section.
1. After
60 days, applicants seeking a Certificate of Free Sale for articles for which a
Certificate was denied must submit a new application in compliance with the terms of
this section.
(e) Applicants
whose applications for a Certificate of Free Sale have been denied have 30 days from
the date the application is denied within which to appeal by submitting a written
appeal to the address specified in (a) above.
1.
The written appeal shall provide the explanation and justification contesting the
denial and any supporting materials and documentation.
(f) The fee schedule for applications for a
Certificate of Free Sale (CFS) is as follows:
1. $
50.00 per CFS containing three or fewer items;
2. $ 75.00 per CFS containing four through nine
items;
3. $ 100.00 per CFS containing 10
through 25 items; and
4. Certificates of
Free Sale that attest to the sanitation or processing of food, cosmetics or drug
products without reference to an individual product shall be assessed a fee of $
50.00.
Notes
See: 36 New Jersey Register 1155(a), 37 New Jersey Register 52(b).
Notice of readoption with technical change, effective
See: 53 N.J.R. 2191(a).
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