- Proyecto de Decreto Supremo que modifica el artículo 103 del Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios; ; -Proyecto de Reglamento que regula la presentación y contenido de los documentos requeridos en la inscripción y reinscripción de productos biológicos: productos biotecnológicos (16 páginas, en español).
Distribution date: 15 April 2015 | Final date for Comment: 14 June 2015
<p style="margin:6pt 0cm 6pt 1cm;"><span lang="ES" style="font-family:Symbol;"><span>·<span style="font:7pt/normal 'Times New Roman';"> </span></span></span><span lang="ES">El proyecto de Decreto Supremo contiene 4 artículos. </span></p><p style="margin:6pt 0cm 6pt 1cm;"><span lang="ES" style="font-family:Symbol;"><span>·<span style="font:7pt/normal 'Times New Roman';"> </span></span></span><span lang="ES">El proyecto de Reglamento contiene 2 títulos, 8 artículos, 3 Disposiciones Complementarias Transitorias y 3 anexos, establece:</span></p><p style="margin:6pt 0cm 6pt 45.35pt;"><span lang="ES"><span>a)<span style="font:7pt/normal 'Times New Roman';"> </span></span></span><span lang="ES">Las normas que regulan la presentación de los documentos requeridos en la inscripción y reinscripción de los productos biológicos: productos biotecnológicos. </span></p><p style="margin:6pt 0cm 6pt 45.35pt;"><span lang="ES" style="font-family:'Verdana','sans-serif';font-size:9pt;">b) La información que deben contener los documentos requeridos en la inscripción y reinscripción de los productos biológicos: productos biotecnológicos.</span></p>
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
Food Safety and Standard (Food Product Standard and Food Additives) Amendment Regulation, 2015, dated 6 February 2015
Distribution date: 16 April 2015 | Final date for Comment: 15 June 2015
The draft Food Safety and Standard (Food Product Standard and Food Additives) Amendment Regulation, 2015, details the standards of Steviol Glycoside in various food articles, [Food Safety and Standards (Food Product Standard and Food Additives) Regulation, 2011: Regulation 3.1.3, 3.2.2].
Products Covered: Steviol Glycoside
Regulation Type: Regular notification
Circular on List of micronutrients allowed to be added for food products
Distribution date: 21 April 2015 | Final date for Comment: 20 June 2015
List of micronutrients allowed to be added for food products.
Products Covered: Vitamins, minerals, micronutrients in foodstuff
Regulation Type: Regular notification
Food Safety and Standard (Food product Standard and Food Additives) Amendment Regulation, 2014 and Food Safety and Standards (packaging and labelling) Amendment Regulation, 2014 dated 11 December 2014
Distribution date: 23 April 2015 | Final date for Comment: 22 June 2015
The draft Food Safety and Standard (Food Product Standard and Food Additives) Amendment Regulation, 2014, details the standards of Carboxymethyl Cellulose (CMC) and natural colour. [Food safety and standards (Food Product Standard and Food Additives) Regulation, 2011: Regulation 3.2.1]. The draft Food Safety and Standards (packaging and labelling) Amendment Regulation, 2014 specify labelling requirement of Carboxymethyl Cellulose. [Food Safety and Standards (packaging and labelling) Regulation, 2011: Regulation 2.4.5].
Products Covered: Carboxymethyl cellulose and natural colour
Regulation Type: Regular notification
<p>TITLE: Agency Information Collection Activities; Proposed Collection; Comment Request; Sun Protection Factor Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products</p><p>AGENCY: Food and Drug Administration, HHS</p><p>ACTION: Notice</p><p>SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Sun Protection Factor (SPF) labeling and testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and marketed without approved applications, and on compliance with Drug Facts labeling requirements for all OTC sunscreen products.</p><p>DATES: Submit either electronic or written comments on the collection of information by 15 June 2015.</p><p>URLs:</p><p>http://www.gpo.gov/fdsys/pkg/FR-2015-04-16/html/2015-08750.htm </p><p>http://www.gpo.gov/fdsys/pkg/FR-2015-04-16/pdf/2015-08750.pdf</p>
Distribution date: 23 April 2015 | Final date for Comment: 04 May 2025
Products Covered: Sunscreen Drug Products (HS: 3304.10-99; ICS: 13, 71.100)
Regulation Type: Addendum to Regular Notification
Sanitation Standard for Food Cleansers
Distribution date: 27 April 2015 | Final date for Comment: 04 May 2025
The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu proposed amendments to the Sanitation Standard for the substances which are used to disinfect or clean food and food-contact surfaces in food utensils, food containers and food packaging, dated 21 November 2014 (G/SPS/N/TPKM/314/Rev.1). The final amendment has entered into force on 27 April 2015. http://members.wto.org/crnattachments/2015/SPS/CHT/15_1790_00_e.pdf http://members.wto.org/crnattachments/2015/SPS/CHT/15_1790_00_x.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Commission Implementing Regulation (EU) 2015/525 of 27 March 2015 amending Annex I to Regulation (EC) No 669/2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin (Text with EEA relevance)
Distribution date: 02 April 2015 | Final date for Comment: 04 May 2025
The Regulation reviews the list of imports of feed and food of non-animal origin which are subject to an increased level of official controls. The changes concern the inclusion in the list of almonds from Australia, pistachios from the United States of America and dried apricots from Uzbekistan.
Products Covered: HS Codes: ex 07049090, ex 07081000, ex 07082000, 07096010, 07093000, ex 07094000, 07096010, ex 07096099, ex 07099990, ex 07102200, 071022, 07108051, ex 07108059, ex 07108095, 07133900, 080211, 080212, 08025100, 08025200, 08051020, 08051080, ex 08054000, 08061010, 080620, 08101000, ex 08109020, 081110, 08131000, 0902, 090420, 09042110, 09042190, ex 09042200, 09081100, 09081200, 091050, 09109105, ex 11063090, 12024100, 12024200, 12074090, ex 12077000, ex 12119086, ex 14049000, 20081110, 20081191, 20081196, 20081198, 20085061, ex 20089999, 3507
Regulation Type: Regular notification
Commission Implementing Regulation (EU) 2015/525 of 27 March 2015 amending Annex I to Regulation (EC) No 669/2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin (Text with EEA relevance)
Distribution date: 02 April 2015 | Final date for Comment: 04 May 2025
The Regulation reviews the list of imports of feed and food of non-animal origin which are subject to an increased level of official controls. The changes concern the inclusion in the list of almonds from Australia, pistachios from the United States of America and dried apricots from Uzbekistan.
Products Covered: HS Codes: ex 07049090, ex 07081000, ex 07082000, 07096010, 07093000, ex 07094000, 07096010, ex 07096099, ex 07099990, ex 07102200, 071022, 07108051, ex 07108059, ex 07108095, 07133900, 080211, 080212, 08025100, 08025200, 08051020, 08051080, ex 08054000, 08061010, 080620, 08101000, ex 08109020, 081110, 08131000, 0902, 090420, 09042110, 09042190, ex 09042200, 09081100, 09081200, 091050, 09109105, ex 11063090, 12024100, 12024200, 12074090, ex 12077000, ex 12119086, ex 14049000, 20081110, 20081191, 20081196, 20081198, 20085061, ex 20089999, 3507
Regulation Type: Regular notification
Letter of the Federal Service for Veterinary and Phytosanitary Surveillance No. FS-EN-8/6139
Distribution date: 29 April 2015 | Final date for Comment: 04 May 2025
The measure represents a temporary restriction on import of live poultry and hatching eggs, poultry meat and all kinds of poultry products, not heat treated (at least 70 °C), feed and feed additives for poultry (except feed additives of chemical and microbiological synthesis), used equipment for keeping, slaughter and butchering of birds, down and feather from Canada (Oxford county, Ontario) to the territory of the Russian Federation due to an outbreak of highly pathogenic avian influenza.
Products Covered: HS Code(s): 0105, 0207, 0505, 1001190000, 1001990000, 1002900000, 1003900000, 1004900000, 1005900000, 1201900000, 1208, 1211, 1213000000, 1214, 2301, 2302, 2303, 230400000, 2306 (except of waste from HS Codes 2304 or 2305), 230800, 2309, 3507, 3923, 3926, 4415, 4416000000, 4421, 702000, 730900, 7310, 7326, 7616, 8436210000, 8436290000, 8436809000, 8606918000, 860900, 871639800, 0407
Regulation Type: Emergency notifications (SPS)
Agreement amending the Agreement establishing the classification and coding of goods the importation of which is subject to regulation by the Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food through the National Agriculture and Food Health, Safety and Quality Service, published on 3 September 2012
Distribution date: 11 May 2015 | Final date for Comment: 04 May 2025
On 7 May 2015, the Mexican Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food (SAGARPA) published in the Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx/) the Agreement amending the Agreement establishing the classification and coding of goods the importation of which is subject to regulation by SAGARPA through the National Agriculture and Food Health, Safety and Quality Service, published on 3 September 2012.The Agreement will enter into force ten working days after its publication in the Official Journal, except for the second and third points, which will enter into force on the day following its publication.Phytosanitary import certificates issued prior to the entry into force of the notified text will remain valid until they expire, in accordance with the terms under which they were issued, and may be used for the purpose for which they were issued, provided that they contain a clear description of the goods concerned (Jamaican sorrel) and that this description is consistent with the goods presented to the customs authority, even if the tariff heading indicated is different to 1211.90.07.http://www.dof.gob.mx/nota_detalle.php?codigo=5391332&fecha=07/05/2015http://members.wto.org/crnattachments/2015/SPS/MEX/15_1937_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
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