This document specifies the quality and safety requirements of Rheum root and rhizome (the dried root and rhizome of Rheum palmatum Linne., Rheum tanguticum Maxim. ex Balf. and Rheum officinale Baill.). This document applies to Rheum root and rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants. This document does not apply to the processing methods and processed products of Rheum root and rhizome.

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This document specifies the minimum requirements and test methods for Coptis rhizome (the dried rhizome of Coptis chinensis Franch. and Coptis japonica Makino.). This document applies to Coptis rhizome sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants. This document does not apply to the processed Coptis rhizome, including products traditionally processed with different methods, or its processing methods.

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This document specifies minimum requirements and test methods for root of Scutellaria baicalensis, which is derived from cultivated Scutellaria baicalensis Georgi. This document applies to Scutellaria baicalensis root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

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There are no changes to the content of the EN 14375 document.
This document specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This document is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

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This document specifies the business requirements for the structured content of structured or semi-
structured dose instructions for recording dose instructions in the electronic health record (EHR),
supporting clinical decision support, and in exchanging medication orders, as applicable to primary,
secondary and tertiary care.
This document is focused on the dose instructions as will be presented to the individual subject of care
or caregiver. Comprehension of dose instructions by the subject of care or caregiver is an overarching
consideration for subject of care safety and the best outcomes. Related factors are discussed but are not
part of the primary scope.
This document does not define an information model, except to the extent that those information model
concepts are necessary to define business requirements.
Outside the scope of this document are:
— The implementation of dose instructions, i.e. assembling the structured elements into a form
appropriate for the patient or caregiver;
— The content of a medication order (see ISO 17523) beyond content related to dose instructions;
— The content of a record of dispense of a medicinal product (see ISO/TS 19293);
— The functionality of health, clinical and/or pharmacy systems;
— Other kinds of content of health, clinical or pharmacy systems that are needed to support the whole
process of health care providers, such as:
— A drug knowledge database (see ISO/TS 22756);
— A decision support system (see ISO/TS 22756 and ISO/TS 22703);
— A complete medical record (EHR);
— A medicinal product dictionary (see ISO/TS 19256);
— Verification of the medicinal product and dose being administered.
— Some concepts from Identification of Medicinal Products are referenced, but not defined, in this
document. See Clause 4 for discussion of the relationship of this document with IDMP.

  • Technical specification
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This document specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This document is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

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    22 pages
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This document specifies the determination of ochratoxin A (OTA) in natural products by the liquid chromatography coupled with fluorescence detector (LC-FLD) method. It is applicable to the analysis of OTA in raw materials and manufactured products, including decoction pieces derived from plants and animals. It is suitable for samples during the processes of harvesting, transportation and storage, as well as domestic and foreign trade for quality classification.

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This document describes the general specifications of temperature-sensitive medicinal packaging based on the principles of good distribution practice (GDP). It also specifies test methods to validate the package performance for temperature-sensitive medicinal products. This covers the procedures of temperature-recording and testing methods on the performance of insulated containers such as dimensions, weights, storage capacity and robustness in temperature-controlling. This document does not guarantee the quality and safety of all medicinal products. Under special circumstances where the weight or the characteristics of the products and environment show specific conditions, agreements are followed. This document does not cover the active packaging system, but only covers the passive packaging system able to control the desired temperature without any power sources.

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This document specifies the testing of preservatives and unwanted compounds within a quality control framework for starting materials and finished products used in and as traditional Chinese medicine.

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This document specifies a set of requirements and a test method to control the quality of fermented Cordyceps powder, including test items such as identification, assay, water content, residue on ignition, microbial limit and heavy metals. It is applicable to fermented Cordyceps powder which is produced by liquid fermentation with extracted strain of Ophiocordyceps sinensis (Berk.).

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    16 pages
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This document specifies the sample preparation methods for the determination of contamination of natural products by heavy metals, pesticides, aflatoxins and microorganisms. It is applicable to raw materials and finished products used in traditional Chinese medicine.

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    11 pages
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This document specifies requirements and recommendations for organizations directly or indirectly involved in the cannabis supply chain, to enable them to: — plan, implement, operate, maintain and update a good production practice programme for providing products that are safe, according to their intended use; — demonstrate compliance with applicable statutory and regulatory requirements; — evaluate and assess mutually agreed customer requirements and demonstrate conformity to them; — effectively communicate with interested parties and demonstrate conformity to relevant interested parties; — demonstrate conformity to stated policies in a cannabis quality programme (CQP) for product safety, product quality, product security and facility safety; — support the evaluation of quality programmes by external organizations or to permit self-assessment or self-declaration of adherence to some or all of the guidance contained in this document. All requirements in this document are generic and intended to be applicable to all organizations in the cannabis supply chain, regardless of size and/or complexity. Organizations that are directly or indirectly involved include (but are not limited to) growers/cultivators, harvesters, primary processors, producers of cannabis, manufacturers of cannabis derivatives, cannabis edibles and/or cannabis products, testing providers, retailers and organizations providing transportation, storage and distribution services, suppliers of equipment, packaging materials and other contact materials. This document intended to enable any organization, including small and/or less developed organizations, to implement externally developed elements in its CQP. NOTE 1 Organizations in the cannabis supply chain are diverse in nature and not all the requirements specified in this document apply to each establishment or process. Justifications for exclusions or the use of alternative measures can be documented by a risk assessment/hazard analysis or other appropriate means. This document provides guidance related to the following categories of cannabis, cannabis derivatives and cannabis products: — cannabis plant seeds; — cannabis plants; — fresh cannabis; — dried cannabis; — cannabis derivatives; — cannabis topicals; — inhalable cannabis. NOTE 2 Annex B provides additional guidance on applying GPP to cannabis edibles with respect to requirements and recommendations in existing food safety standards. Where buildings or premises combine cultivation and processing of cannabis plants, including ancillary activities, along with other operational activities, the requirements and recommendations in this document apply only to that portion of the facility. NOTE 3 Where joint use activities are present in a common building, specific statutory and regulatory requirements can apply for each category. This document does not address the following: — requirements related to research and development activities for finished products; — general fire prevention or building construction features that are normally a function of local building and fire codes where applicable; — premises used exclusively for operational activities, such as office space, call centres and retail outlets, used for the distribution, marketing, or sale of cannabis; NOTE 4 Shipping and receiving of products from the production facility for further distribution are not considered as a retail outlet. — the safe consumption or use of the cannabis or cannabis products produced by organizations applying these good production practices; — occupational health and safety requirements governing cannabis workers and personnel except as identified in A.8.4 and A.8.6; — the protection of the environment; — security of the supply chain monitoring system, including cybersecurity and notifications; NOTE 5 Security and monitoring of the supply chain are dealt with specifically in IWA 37-2. — outdoor cultivation of cannabis and industrial hemp; — gr

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This document specifies the shape, dimensions, fill capacities and performance requirements of moulded glass bottles for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. This document also provides requirements for packaging of the moulded glass bottles and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or amber glass containers moulded from borosilicate or soda-lime-silica glass and intended to be used in the packaging, storage or transportation of products intended for medicinal use.

  • Standard
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This document specifies the shape, dimensions, fill capacities and performance requirements of plastic bottles for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. The document provides requirements for packaging of the plastic bottles and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or coloured containers moulded from plastic and intended to be used in the packaging, storage or transportation of products intended for medicinal use.

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    18 pages
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This document specifies the shape, dimensions, fill capacities and performance requirements of tubular glass vials for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. This document provides also requirements for packaging of the tubular glass vials and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or amber containers made of tubular glass and intended to be used for packaging, storage or transportation of products intended for medicinal use.

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This document specifies the quality and safety requirements of Saposhnikovia divaricata root and rhizome derived from the plant of Saposhnikovia divaricata (Turcz.) Schischk. It is applicable to Saposhnikovia divaricata root and rhizome that is sold as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

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    18 pages
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This document specifies the content of electronic labelling in the form of QR codes on the outer packing of Chinese materia medica and decoction pieces. This document is applicable to the cultivation, production, sales, use units and consumers of Chinese materia medica and decoction pieces.

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This document specifies the requirements for process traceability systems in Chinese materia medica and decoction pieces, including checkpoints of traceability information about the planting or breeding and circulation of Chinese materia medica, and the manufacturing, processing and use of entities of decoction pieces.

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This document specifies the minimum quality and safety requirements of Sinomenium acutum stem [the dried lianoid stem of Sinomenium acutum (Thunb.) Rehd. et Wils. and Sinomenium acutum (Thunb.) Rehd. et Wils. var. cinereum Rehd. et Wils.]. This document applies to Sinomenium acutum stem that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants.

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This document specifies the minimum requirements and test methods for white peony root derived from the plant of Paeonia lactiflora Pallas. It is applicable to white peony root that is sold as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. It is not applicable to red peony root.

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This document specifies the minimum requirements and test methods for Codonopsis pilosula root derived from the plant of Codonopsis pilosula (Franch.) Nannf. It is applicable to Codonopsis pilosula root that is sold as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

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This document specifies minimum requirements and test methods for Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root. This document applies to Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.

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This document specifies the method for the determination of benzopyrene content in processed natural products. It is applicable to processed natural products such as processed Rehmannia root, processed Cyperus rhizome, processed ginseng and processed mume fruit. It is not applicable to the analysis of minerals used in traditional Chinese medicine.

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This document specifies general requirements for manufacturing procedures and quality and safety assurance of granules and compactates made from traditional Chinese medicine extracts or powder for oral use. This document excludes granules or compactates made from pure compounds (chemically defined) even if they are isolated as naturally occurring constituents of decoction pieces or crude herbal and mineral drugs.

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This document specifies the requirements for medication safety alert systems and the topics which are
relevant to alert system vendors. This document applies to clinical decision support systems (CDSSs)
whether or not these are medical devices.
This document addresses:
— requirements for terminology used in medication safety alerts;
— requirements for choosing a knowledge base for medication safety alert systems;
— requirements for the proper functionality of CDSSs as related to medication safety alert systems;
— requirements for medication safety alert display;
— requirements for quality measurements to improve the effectiveness of medication safety alerts.
The following are out of the scope of this document:
— the development of content (rule-based knowledge base) for CDSS;
— the development of algorithms for generating medication safety alerts in CDSS;
— the development of alert processors for medication safety alerts in CDSS.

  • Technical specification
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This document specifies the quality and safety requirements of Zingiber officinale rhizome derived from the plant Zingiber officinale Roscoe, including the minimum requirements and test methods. This document applies to Zingiber officinale rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. It is not applicable to Zingiber officinale rhizome sold and used as food or spices.

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This document specifies test methods to determine microorganisms in natural products. It is applicable only to natural products used in traditional Chinese medicine, including raw materials, herbal pieces and preparations.

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This document specifies the quality and safety requirements of Glehnia littoralis root, which is derived from the plant Glehnia littoralis Fr Schmidt ex Miq. This document applies to Glehnia littoralis root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

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This document specifies the general requirements and test methods for herbal raw material and materia medica. This document provides minimum requirements for those herbal materials that are not covered by individual standards.

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This document specifies minimum requirements and test methods for processed Aconitum carmichaelii lateral root (lateral root of Aconitum carmichaelii Debx.). This document applies to processed Aconitum carmichaelii lateral root that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. Processing methods of Aconitum carmichaelii lateral root are excluded.

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This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.

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This document specifies a method for using high-performance liquid chromatography (HPLC) to determine the presence of aristolochic acid I in natural products.

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This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

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This Technical Reports describes quality designations and indications for algae and directly derived products from algae production required for or by pharma producers and industry. It does not apply to Food and Feed sectors.
Note: This TRs does not provide instructions on existing handling of technical requirements in existing legislations.

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This document specifies requirements for controls on the sourcing, collection, and handling (which
includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing
materials of animal origin other than in vitro diagnostic medical devices. It applies where required by
the risk management process as described in ISO 22442-1.
NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk
management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine
species, deer, elk, mink or cats.
This document does not cover the utilization of human tissues in medical devices.
This document does not specify a quality management system for the control of all stages of production
of medical devices.

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This document applies to medical devices other than in vitro diagnostic medical devices manufactured
utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It
specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations
associated with such devices, to estimate and evaluate the resulting risks, to control these risks,
and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the
residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and
expected medical benefit as compared to available alternatives. This document is intended to provide
requirements and guidance on risk management related to the hazards typical of medical devices
manufactured utilizing animal tissues or derivatives such as:
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing transmissible spongiform encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This document does not stipulate levels of acceptability which, because they are determined by a
multiplicity of factors, cannot be set down in such an international standard except for some particular
derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow
derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
This document does not specify a quality management system for the control of all stages of production
of medical devices.
This document does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture.
However, attention is drawn to international standards for quality management systems (see ISO 13485) that
control all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this document, see Annex A.

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This document specifies requirements for identity testing within a quality control framework for raw materials and finished products used in and as traditional Chinese medicine (TCM) and derivative forms. It is applicable to natural products used in TCM, including starting materials and finished products of herbal origin.

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This document specifies general requirements within a quality control framework for raw materials and finished products used in and as traditional Chinese medicine (TCM) and derivative forms, and the comparison between the starting materials and the finished products, if necessary.

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This document provides a referenced entry-level implementation template for traditional Chinese medicine decoction piece prescriptions based on HL7 CDA® Release 2.0 to support the data collection, transmission, storage and exchange of decoction piece prescriptions for electronic records. This document focuses on the description of core data of traditional Chinese medicine decoction piece prescriptions which constitute the 'medication administration' section of the clinical document body. This document does not specify the detailed content of the clinical document header or other sections and entries of the clinical document body.

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This document specifies the determination method of sulfur dioxide in natural products used in traditional Chinese medicine, which includes the requirements of the device, chemicals, operational procedures and formula. It is applicable to natural products of traditional Chinese medicine, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants or animals. It is not applicable to minerals used in traditional Chinese medicine.

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This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

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This document specifies the minimum requirements and test methods for Lycium barbarum and Lycium chinense fruit, which is derived from the plant of Lycium barbarum L. or Lycium chinense Mill. It is applicable to Lycium barbarum and Lycium chinense fruit that is sold and used as herbal raw materials in the international trade, including unprocessed and traditionally processed materials.

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This document specifies the methods for the determination of aflatoxins (AFB1, AFB2, AFG1, AFG2) in natural products using LC-FLD. It is applicable to the analysis of aflatoxins in raw materials and manufactured products, including decoction pieces derived from plants and animals.

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This document specifies methods for the determination of the selected Aconitum alkaloids, including aconitine, mesaconitine, hypaconitine, benzoylaconine, benzoylmesaconine, benzoylhypaconine, yunaconitine, deacetyl-yunaconitine and crassicauline A.

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This document specifies the method of determination of pesticide residues in natural products used in traditional Chinese medicine (TCM) by gas chromatography (GC), including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants.

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This document specifies the methods for microscopic examination of medicinal herbs. It covers the equipment, sampling, preparation and observation methods. This document is applicable to medicinal herbs used in traditional Chinese medicine, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants. It is not applicable to medicinal materials derived from animals or minerals.

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This document specifies a method using photostimulated luminescence (PSL) to detect the radiation status of natural products. It can be used to identify whether raw and traditionally processed Chinese medicinal materials and solid forms of manufactured product made from these materials have been irradiated by ionizing radiation (gamma, X-ray or beam). It is not applicable for use in testing liquid dosage forms or partially solid extracted dosage forms that do not contain directly crushed medicinal materials.

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This document specifies the quality and safety requirements of Astragalus mongholicus root [root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao]. This document applies to Astragalus mongholicus root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

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    19 pages
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This document specifies minimum requirements and test methods for Angelica sinensis root that is derived from Angelica sinensis (Oliv.) Diels. It is applicable to Angelica sinensis root that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

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