Draft Gulf technical regulation on toys for under 14 years of age (26 pages, in Arabic).
Distribution date: 21 November 2007 | Final date for Comment: 24 April 2025
Products Covered: Toys defined as any product or material designed or clearly intended for use in play by children of less than 14 years of age
Regulation Type: Regular notification
Partial revision of the Japanese Pharmacopoeia Fifteenth edition (1 page, available in English).
Distribution date: 21 November 2007 | Final date for Comment: 24 April 2025
Products Covered: Drugs (HS: 30)
Regulation Type: Regular notification
National Standard of the P.R.C., Triple superphosphate (10 pages, in Chinese).
Distribution date: 30 November 2007 | Final date for Comment: 24 April 2025
Products Covered: Triple superphosphate ICS: 65.080, HS: 31
Regulation Type: Regular notification
National Standard of the P.R.C., Athletic Shoes (8 pages, in Chinese).
Distribution date: 30 November 2007 | Final date for Comment: 24 April 2025
Products Covered: Athletic Shoes ICS: 61.060, HS: 3405
Regulation Type: Regular notification
Reglamento sobre el Registro, Uso y Control de Fertilizantes y Materias Primas (Regulation governing the registration, use and control of fertilizers and raw materials) (16 pages, in Spanish)
Distribution date: 03 December 2007 | Final date for Comment: 01 February 2008
The notified Regulation seeks to establish technical, administrative and legal provisions within the framework of the Ley Fitozoosanitaria (Plant and Animal Health Law) with regard to the registration, import, manufacture, formulation, repacking, repackaging, transport, storage, sale, use, handling and export of fertilizers and agricultural raw materials.This Regulation does not apply to substances used as laboratory materials or reagents.
Products Covered: Fertilizers and agricultural raw materials
Regulation Type: Regular notification
Summary of Amendments of the Standard for Biological Product for Animal Use (1 page, available in English). Draft of Amendments of the Standard for Biological Product for Animal Use (35 pages, available in Japanese),
Distribution date: 07 December 2007 | Final date for Comment: 24 April 2025
Products Covered: Vaccines for Veterinary medicine (HS: 3002.30)
Regulation Type: Regular notification
Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to the Direct Final Rule (4 pages, in English).
Distribution date: 10 December 2007 | Final date for Comment: 24 April 2025
The Food and Drug Administration (FDA) has published a companion proposed rule to the direct final rule: http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/E7-23294.htm which amends certain sections of the regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
Products Covered: Pharmaceuticals (HS: Ch. 30; ICS: 11.120, 71.020)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Radiopharmaceuticals (1 page, available in English).
Distribution date: 10 December 2007 | Final date for Comment: 24 April 2025
Products Covered: Drugs (HS: 30)
Regulation Type: Regular notification
Draft Commission Directive setting up, pursuant to Council Directive 93/15/EEC, a system for the identification and traceability of explosives for civil uses (9 pages, in all official languages of the EU).
Distribution date: 13 December 2007 | Final date for Comment: 24 April 2025
Products Covered: Explosives (HS: 3601, 3602, 3603)
Regulation Type: Regular notification
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Proposed Rule (30 pages, in English).
Distribution date: 13 December 2007 | Final date for Comment: 24 April 2025
The Food and Drug Administration (FDA) proposes to revise and update the regulations applicable to blood and blood components, including Source Plasma and Source Leukocytes, to add donor requirements that are consistent with current practices in the blood industry, and to more closely align the regulations with current FDA recommendations.
Products Covered: Human blood (HS: 3002) (ICS: 11)
Regulation Type: Regular notification
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